Identity
- Trade Name
- Alumi-Hand PLUS FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Device Name
- The Alumi-Hand PLUS is a ready to use STERILE Hand Immobilizer offering new ways of holding the digits unlike any other Hand Immobilizer on the market. Made of pliable aluminum and foam, lead free, latex free and X-ray compatible. Patent Pending. Case of 8 FDA UDI
- Model / Reference
- KH-860-8 FDA UDI
- Description
- The Alumi-Hand PLUS is a ready to use STERILE Hand Immobilizer offering new ways of holding the digits unlike any other Hand Immobilizer on the market. Made of pliable aluminum and foam, lead free, latex free and X-ray compatible. Patent Pending. Case of 8 FDA UDI
Identifiers
- Catalog Number
- KH-860-8 FDA UDI
- Primary DI / UDI-DI
- 00810045928784 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Limb/torso/head restraint, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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: Limb/torso/head restraint, single-use
Alumi-Hand PLUS by Instrument Specialists, 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
- Instrument Specialists, Inc.
Sources (1)
- FDA UDI ea72c200-60b6-49d2-8b56-83ca3965c840 34 fields · synced May 30, 2026