Identity
- Trade Name
- Gripper Hinged Knee FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Model / Reference
- 117082-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802357000067 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Knee support orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Knee support orthosis
A comprehensive medical device directory, providing detailed information about the Gripper Hinged Knee orthotic device. This device is designed to support and align the knee joint, offering improved function and comfort for individuals with joint pain or deformities.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medical Specialties Incorporated
Sources (1)
- FDA UDI d5a303d9-8b0c-46ad-8fc7-5173e1108eae 32 fields · synced Jul 21, 2026