Identity
- Trade Name
- Sterling FDA UDI
- Generic Name
- External limb prosthesis socket liner FDA UDI
- Device Name
- Sterling Liner Kit, Gel, 9mm, Cushion, Uniform, Medium+, 2 pack FDA UDI
- Model / Reference
- SLK G9C UM+2 FDA UDI
- Description
- Sterling Liner Kit, Gel, 9mm, Cushion, Uniform, Medium+, 2 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841747186813 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
Sterling by College Park Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External limb prosthesis socket liner.
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- Duragel Cushion Liner, Uniform, 9mm, Large — SILIPOS Holding LLC · Class I
- Duragel Suspension Sleeve, Medium+, Distal+ - Camo — SILIPOS Holding LLC · Class I
- 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 bbd0e696-7054-43af-8381-24176a7ddb18 33 fields · synced Jun 8, 2026