FDA UDI
In Commercial Distribution
🇺🇸 United States
Medegen Medical Products, LLC
DI: 00700812013075
·
Model: WLK1001
·
MEDEGEN MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Medegen Medical Products, LLC
- Primary DI
- 00700812013075
- Version / Model
- WLK1001
- Company Name
- MEDEGEN MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 055527753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-09-20
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 39f93618-6836-4984-a4d9-ca8030df0692
Device Description
Walker: Folding 1-Button 32-36in 4/Cs
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ITJ | WALKER, MECHANICAL | Physical Medicine | 890.3825 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17105 | Walking aid handgrip | A device designed to help a person using a walking aid to grasp the walking aid (e.g., a walking stick, cane, crutch, walking frame or rollator) securely. Included are adjustable grips, grips with antislip material and grips of special material such as foam. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00700812013075 | GS1 | ||||
| Unit of Use | 10700812013072 | GS1 |