Identity
- Trade Name
- Stat-A-Dyne Shoulder FDA UDI
- Generic Name
- Multiple-joint arm orthosis FDA UDI
- Device Name
- Orthosis providing flexion and extension of shoulder FDA UDI
- Model / Reference
- Shoulder FDA UDI
- Description
- Orthosis providing flexion and extension of shoulder FDA UDI
Identifiers
- Catalog Number
- Shoulder FDA UDI
- Primary DI / UDI-DI
- B770SH0 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Multiple-joint arm 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: Multiple-joint arm orthosis
Stat-A-Dyne Shoulder by Lantz Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-joint arm orthosis.
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- Universal Hemi-sling — MEDICAL SPECIALTIES INCORPORATED · Class I
- PROFIT — PANTYMED S.A. · Class I
- PROFIT — PANTYMED S.A. · Class I
- NON FRANCHISE — DJO, 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
- Lantz Medical
Sources (1)
- FDA UDI 2ab113a0-2805-46b4-95fd-526d2319d665 34 fields · synced May 30, 2026