FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DRIVE
DI: 00822383000732
·
Model: RTL10372PL
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVE
- Primary DI
- 00822383000732
- Version / Model
- RTL10372PL
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-08
- Public Version
- 2
- Public Version Date
- 2020-04-24
- Public Version Status
- Update
- Public Device Record Key
- fdb416bf-23bb-4a80-9e04-87cc104a975a
- Distribution End Date
- 2020-04-24
Device Description
Canes & Crutches Offset Product Description Cane, Offset Gel Grip, Plaid, 1/ea,6/cv
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IPS | CANE | Physical Medicine | 890.3075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31115 | Axillary crutch | A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383000732 | GS1 | ||||
| Previous | 00822384002612 | GS1 |