FDA UDI
In Commercial Distribution
🇺🇸 United States
MEIJER
DI: 00713733215572
·
Model: 713733215572
·
MEIJER, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEIJER
- Primary DI
- 00713733215572
- Version / Model
- 713733215572
- Company Name
- MEIJER, INC.
- Labeler DUNS
- 006959555
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-08
- Public Version
- 1
- Public Version Date
- 2023-03-16
- Public Version Status
- New
- Public Device Record Key
- 880fa8e0-85d4-44dc-84dd-4d954e6f4b7f
Device Description
MEIJER GEL BUNION CUSHION
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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61907 | Hallux valgus metatarsophalangeal orthosis | A prefabricated (non-customized) non-rigid, home-use device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation. It is made of elastic fabric materials and may encompass only the metatarsophalangeal region or extend around the heel for tensioning. This is a single-patient reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00713733215572 | GS1 |