Identity
- Trade Name
- Drive FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- Part Rollators Parts Product Description Fusion/Excursion Frame Bolt set, 1/ea FDA UDI
- Model / Reference
- B01-602 FDA UDI
- Description
- Part Rollators Parts Product Description Fusion/Excursion Frame Bolt set, 1/ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383011233 FDA UDI
- FDA Product Code
- ITJ FDA UDI
- GMDN Term
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3825 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Handgrip disability-assistive walker, non-powered, foldable
Drive by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- R82 — R82 A/S · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI fd0d8562-2ee9-4cf9-9baa-a24af8c4da04 33 fields · synced Jun 8, 2026