Identity
- Trade Name
- RegenKit Wound-Gel FDA UDI
- Generic Name
- Blood collection set, noninvasive FDA UDI
- Device Name
- . FDA UDI
- Model / Reference
- RK-WG-1 FDA UDI
- Description
- . FDA UDI
Identifiers
- Catalog Number
- SE-RK-WG-1 FDA UDI
- Primary DI / UDI-DI
- 00850033131093 FDA UDI
- FDA Product Code
- PMQ FDA UDI
- GMDN Term
- Blood collection set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood collection set, noninvasive
RegenKit Wound-Gel by Regenlab USA LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Regenlab USA LLC
Sources (1)
- FDA UDI d94786a4-eb6f-4145-91ff-6a42065ea024 34 fields · synced Jun 6, 2026