Identity
- Trade Name
- Stat-A-Dyne Elbow FDA UDI
- Generic Name
- Elbow orthosis FDA UDI
- Device Name
- Orthosis providing flexion and extension of elbow FDA UDI
- Model / Reference
- Elbow FDA UDI
- Description
- Orthosis providing flexion and extension of elbow FDA UDI
Identifiers
- Catalog Number
- Elbow FDA UDI
- Primary DI / UDI-DI
- B770EL0 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Elbow orthosis
Stat-A-Dyne Elbow by Lantz Medical — 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
- NEOPRENE TENNIS ELBOW LONG — BIRD & CRONIN, LLC · Class I
- BMI — Blake Manufacturing, Inc. · Class I
- MEDI — MEDI MANUFACTURING, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lantz Medical
Sources (1)
- FDA UDI 4ca34d90-0f67-4c71-9082-4ba5bb9bf2c6 34 fields · synced May 30, 2026