FDA UDI
In Commercial Distribution
🇺🇸 United States
BREG
DI: 00672736013977
·
Model: HEEL CUP SILICONE L
·
BREG, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BREG
- Primary DI
- 00672736013977
- Version / Model
- HEEL CUP SILICONE L
- Catalog Number
- 11094
- Company Name
- BREG, INC.
- Labeler DUNS
- 604483321
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-13
- Public Version
- 1
- Public Version Date
- 2023-06-21
- Public Version Status
- New
- Public Device Record Key
- eaa92108-3689-46d8-b89e-848144ab0f71
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KYS | Insoles, Medical | General Hospital | 880.6280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone 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 the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00672736013977 | GS1 |
Customer Contacts
- Phone
- 8003210607
- [email protected]