Identity
- Trade Name
- Guardian Splint FDA UDI
- Generic Name
- Assistive dynamic arm support system FDA UDI
- Device Name
- This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas. FDA UDI
- Model / Reference
- GGP-R FDA UDI
- Description
- This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809818038227 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Assistive dynamic arm support system 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 250 Millimeter FDA UDIWidth — 105 Millimeter FDA UDI
Category: Assistive dynamic arm support system
Guardian Splint by Bm Korea Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive dynamic arm support system.
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- Harmony SHR™ — Harmonic Bionics, Inc. · Class II
- Harmony SHR™ — Harmonic Bionics, Inc. · Class II
- Harmony SHR™ — Harmonic Bionics, Inc. · Class II
- Well at Walgreens — WALGREEN CO. · 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
- Bm Korea Co., Ltd
Sources (1)
- FDA UDI 857b53c7-f0ef-46f8-913f-d845a8b9cfb7 34 fields · synced Jun 8, 2026