FDA UDI
In Commercial Distribution
🇺🇸 United States
Drive
DI: 00822383989952
·
Model: 146-RTL2046
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Drive
- Primary DI
- 00822383989952
- Version / Model
- 146-RTL2046
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 1
- Public Version Date
- 2019-07-01
- Public Version Status
- New
- Public Device Record Key
- 21b07e7e-d149-40f2-9629-ec9bed898d30
Device Description
Personal CareAids to Daily Living Product Description: Shoe Horn,Blue,22",1EA,12/CS
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
- Yes
- 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 |
|---|---|---|---|---|
| ILD | ADAPTOR, DRESSING | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31051 | Assistive shoehorn/bootjack | A device designed as a modified shoehorn or bootjack to assist a person with a disability to put on and take off their footwear (shoes or boots). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50822383989957 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00822383989952 | GS1 |