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Plastalume
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10105 Model AB-4 3 1/4" (83mm)
Identity
- Trade Name
- DIGITALS EUDAMEDPlastalume FDA UDI
- Generic Name
- Hand/finger splint, reusable FDA UDI
- Device Name
- PLASTALUME® DIGITALS EUDAMEDDigitals FDA UDI
- Model / Reference
- 10105 EUDAMEDFDA UDIAB-4 3 1/4" (83mm) EUDAMED
- Description
- Digitals FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821611010550 EUDAMED00082161101055 FDA UDI
- Basic UDI-DI
- 082161PDAB43C EUDAMED
- FDA Product Code
- LIH FDA UDI
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
- GMDN Term
- Hand/finger splint, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (2)
- FDA UDI 2627ef9e-8a15-4796-b90f-9c1eba14cd9a 33 fields · synced Jun 18, 2026
- EUDAMED f20c0f9c-5a00-4018-b0c0-0d80db32f436 61 fields · synced Jun 18, 2026