Devices

Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)

Model / Serial
Lot 1C00776 No 510K since this is Class I exempt.
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT.
Product Description
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) || Required for application to a patient immediately after ostomy surgery.
Manufacturer
Convatec Inc.
1 Event
- Recall of Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)

Manufacturer

Convatec Inc.

Manufacturer Address
Convatec Inc., 200 Headquarters Park Drive, Skillman NJ 08558-2600
Manufacturer Parent Company (2017)
Triona Holding Sa
Source
USFDA

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