International Medical Devices Database

Manufacturer Address
Shelhigh Inc, 650 Liberty Ave, Union NJ 07083-8130
Source
USFDA
1 Event
- Recall of Device Recall EnDura

One device in the database

Device Recall EnDura

Model / Serial
Lot#, Catalog #, Description: 030911-NR, ENR-20210, 2CM X 10CM; 030911-NR, ENR-20404, 4CM X 4CM; 030911-NR, ENR-20506, 5CM X 6CM; 030808-NR, ENR-20610, 6CM X 10CM; 030811-NR, ENR-20610, 6CM X 10CM; 030911-NR, ENR-21012, 10CM X 12CM; 030924-NR, ENR-21012, 10CM X 12CM; 031027-NR, ENR-21212, 12CM Diameter.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
Yes
Distribution
The product is distributed natiowide to 19 different hospitals.
Product Description
EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.

2 manufacturers with a similar name

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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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Shelhigh Inc

One device in the database

Device Recall EnDura

2 manufacturers with a similar name

Shelhigh Inc.

Shelhigh Incorporated