FDA UDI
In Commercial Distribution
🇺🇸 United States
Guardian Splint
DI: 08809818038227
·
Model: GGP-R
·
BM KOREA CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Guardian Splint
- Primary DI
- 08809818038227
- Version / Model
- GGP-R
- Company Name
- BM KOREA CO., LTD
- Labeler DUNS
- 557799209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 1
- Public Version Date
- 2025-03-31
- Public Version Status
- New
- Public Device Record Key
- 857b53c7-f0ef-46f8-913f-d845a8b9cfb7
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILH | Splint, Hand, And Components | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48071 | Assistive dynamic arm support system | An assembly of mechanical devices designed to bear the weight of a weak or paralysed arm providing gravity-compensating support for the functional use and/or rehabilitation of the arm/wrist/hand. It is used to support activities of daily life (ADL) such as feeding, self care, computer use, as well as therapeutical training and prevention of complaints of neck and/or shoulder (CANS). It consists of a main column anchored to a surface or wheelchair and a suspended sling or a set of components which take the weight bearing through a set of axes, joints, and a splint underneath the user's arm. Gravity compensation works via a counterweight or spring mechanism and a power-assistive electromotor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809818038227 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 250 | Millimeter | |
| Width | 105 | Millimeter |