Devices

ENT Pack

Model / Serial
Lot Numbers/Expiration Dates: 63064 11/3/2015 64818 1/4/2016 71870 12/17/2016 72451 1/7/2017 73240 3/8/2017 72702 3/30/2017 77335 8/10/2017 81025 1/3/2018
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Product Description
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
- Recall of ENT Pack

Manufacturer

Windstone Medical Packaging, Inc.

Manufacturer Address
Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
Manufacturer Parent Company (2017)
Windstone Medical Packaging Inc.
Source
USFDA

196 devices with a similar name

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BD Onclarity HPV Assay Reagent Pack

Model / Serial
Catalog 442946; Lot: 5156775
Product Description
It is an amplified DNA test for the qualitative detection of high-risk types of Human Papilloma Virus (HPV).
Manufacturer
BECKTON DICKINSON || Importer: BECKTON DICKINSON COLOMBIA LTDA

TOTAL BHCG II REAGENT PACK/TOTAL BHCG II CALIBRATOR

Model / Serial
6802220/6802221. Lots: 1410, 1420, 1430, 1440, 1450, 1460, || 1470.
Product Description
THESE PRODUCTS ARE USED FOR THE QUANTITATIVE DETERMINATION OF GONODOTROPINACORIONICA AND SUBUNIDAD B IN SERUM AND PLASMAHUMANOS
Manufacturer
JOHNSON & JOHNSON || Importer: JOHNSON & JOHNSON DE COLOMBIA S.A

total BHCG II Reagent Pack / Total BHCG II calibrator

Model / Serial
Reference 6802220/6802221. Lots: 1410, || 1420, 1430, 1440, 1450, 1460, 1470
Product Description
THESE PRODUCTS ARE USED FOR THE QUANTITATIVE DETERMINATION OF GONODOTROPINACORIONICA AND SUBUNIDAD B IN SERUM AND PLASMAHUMANOS
Manufacturer
ORTHO CLINICAL DIAGNOSTICS || Importer: JOHNSON & JOHNSON DE COLOMBIA S.A

Vitros immunodiagnostic products TSH reagent pack

Model / Serial
PRODUCT CODE: 1912997 || (10758750000227) || LOT: 5430
Manufacturer
ORTHO CLINICAL DIAGNOSTICS COLOMBIA S.A.S. || Importer: ORTHO CLINICAL DIAGNOSTICS, INC.

Vitros Immunodiagnostic Products NT PROBNP Reagent Pack

Model / Serial
Manufacturer
manufacturer #121

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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