Identity
- Trade Name
- Plastalume FDA UDI
- Generic Name
- Hand/finger splint, reusable FDA UDI
- Device Name
- DIGIWRAP TOO™ FDA UDI
- Model / Reference
- 10331 FDA UDI
- Description
- DIGIWRAP TOO™ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00082161103318 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Hand/finger splint, reusable 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
No
FDA UDI
Over-the-Counter
Yes
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: Hand/finger splint, reusable
Plastalume by Brownmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
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- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- McKie Thumb Splint Adult — McKie Splints, LLC · Class I
- Shaped vacuum leg splint TL125 — Mediseam Oy · 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
- Brownmed, Inc.
Sources (1)
- FDA UDI c1b6dd25-6a24-4e5b-b43a-17b53660411f 33 fields · synced May 30, 2026