Identity
- Trade Name
- L'TIMATE ELBOW SLEEVE MD FDA UDI
- Generic Name
- Elbow orthosis FDA UDI
- Model / Reference
- 08145763 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570019601 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Elbow 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
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: Elbow orthosis
L'timate Elbow Sleeve Md by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elbow orthosis.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DONJOY PERFORMANCE — DJO, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BMI — Blake Manufacturing, Inc. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- BMI — Blake Manufacturing, Inc. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- PROFIT — PANTYMED S.A. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bird & Cronin, Llc
Sources (1)
- FDA UDI ce5903a4-66b5-49cb-87a4-4ce2724e0060 32 fields · synced Jun 6, 2026