Identity
- Trade Name
- Gelzone® Shoulder Sleeve FDA UDI
- Generic Name
- Compression/pressure shirt/pants FDA UDI
- Device Name
- Shoulder Traction Device FDA UDI
- Model / Reference
- SLV634 FDA UDI
- Description
- Shoulder Traction Device FDA UDI
Identifiers
- Catalog Number
- SLV634 FDA UDI
- Primary DI / UDI-DI
- M724SLV6341 FDA UDI
- FDA Product Code
- HST FDA UDI
- GMDN Term
- Compression/pressure shirt/pants FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compression/pressure shirt/pants
Gelzone® Shoulder Sleeve by Implantech Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Implantech Associates, Inc.
Sources (1)
- FDA UDI b698ac20-d107-4e5b-b9ef-592526e0200d 35 fields · synced Jun 9, 2026