Identity
- Trade Name
- L'TIMATE HINGED KNEE W/LATERAL PULL 4XL FDA UDI
- Generic Name
- Knee sling FDA UDI
- Model / Reference
- 50008448 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570188536 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Knee sling 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
No
FDA UDI
Category: Knee sling
L'timate Hinged Knee W/Lateral Pull 4xl by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee sling.
- BALANCED SUSPENSION SLING, SIZE M — Mizuho Orthopedic Systems, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BALANCED SUSPENSION SLING, SIZE L — Mizuho Orthopedic Systems, Inc. · Class I
- SLING, KNEE, KODEL — Mizuho Orthopedic Systems, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- HKO ANTERIOR CLOSURE KNEE 5XL — BIRD & CRONIN, LLC · Class I
- HKO ANTERIOR CLOSURE KNEE MD BAG — BIRD & CRONIN, 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
- Bird & Cronin, Llc
Sources (1)
- FDA UDI 8198a764-0c71-451b-9985-25fc6bd63511 32 fields · synced May 30, 2026