Identity
- Trade Name
- 20'' DLX POST-OP KNEE IMMOB FDA UDI
- Generic Name
- Knee immobilizer FDA UDI
- Device Name
- Medium FDA UDI
- Model / Reference
- 462-0014-40 FDA UDI
- Description
- Medium FDA UDI
Identifiers
- Catalog Number
- 462-0014-40 FDA UDI
- Primary DI / UDI-DI
- 00609271200357 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Knee immobilizer 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
Yes
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 immobilizer
20'' Dlx Post-Op Knee Immob by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · 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
- DARCO International, Inc.
Sources (1)
- FDA UDI d9283a2a-2a07-4a47-9601-4d8762b67565 34 fields · synced Jun 9, 2026