FDA UDI
In Commercial Distribution
🇺🇸 United States
PROFIT
DI: 07798128673000
·
Model: 1202-H1 U M
·
PANTYMED S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROFIT
- Primary DI
- 07798128673000
- Version / Model
- 1202-H1 U M
- Company Name
- PANTYMED S.A.
- Labeler DUNS
- 971365986
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-14
- Public Version
- 1
- Public Version Date
- 2024-02-22
- Public Version Status
- New
- Public Device Record Key
- 5a4fcd99-e8a8-4249-a44e-e0baf1cdeeed
Device Description
SHOULDER SUPPORT - SIZE M
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IQI | Orthosis, Limb Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41466 | Multiple-joint arm orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the arm. It is designed to support the elbow and at least one additional joint (i.e., shoulder and/or wrist) and may additionally support the hand. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07798128673000 | GS1 |