Identity
- Trade Name
- Genesee FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- Genesee Liner Kit, Gel, 6mm, Lock, Uniform, Medium FDA UDI
- Model / Reference
- GLK G6L UM1 FDA UDI
- Description
- Genesee Liner Kit, Gel, 6mm, Lock, Uniform, Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841747172021 FDA UDI
- FDA Product Code
- IPM FDA UDI
- GMDN Term
- External limb prosthesis socket liner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External limb prosthesis socket liner
Introducing the Genesee Liner Kit, a flexible device designed to enhance the comfort and stability of external upper or lower limb prostheses. This innovative product is specifically engineered to form an interface between the socket and residual limb, ensuring optimal fit and function.
Similar devices
Also classified as External limb prosthesis socket liner.
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- One — WillowWood Global LLC · Class I
- One — WillowWood Global LLC · Class I
- Duragel Cushion Liner, Uniform, 6mm, Medium — SILIPOS Holding LLC · Class I
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
- College Park Industries, Inc.
Sources (1)
- FDA UDI 992c6db8-44ec-486c-9400-ab2c936a861b 33 fields · synced Jul 25, 2026