Identity
- Trade Name
- Tenderlett Finger Incision Device FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Tenderlett Finger Incision Device 5000/box FDA UDI
- Model / Reference
- TL5000I FDA UDI
- Description
- Tenderlett Finger Incision Device 5000/box FDA UDI
Identifiers
- Catalog Number
- TL5000I FDA UDI
- Primary DI / UDI-DI
- 20711234308186 FDA UDI
- 510(k) Number
- K923302 FDA UDI
- FDA Product Code
- FMK FDA UDI
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 0.94 Millimeter FDA UDIDepth — 1.75 Millimeter FDA UDI
Tenderlett Finger Incision Device by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accriva Diagnostics Holdings, Inc.
Sources (1)
- FDA UDI cb864bdc-fe34-4d43-8a0f-fd7f7dd25971 38 fields · synced May 30, 2026