Identity
- Trade Name
- Genteel FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- The Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood. FDA UDI
- Model / Reference
- Genteel Lancing Device FDA UDI
- Description
- The Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood. FDA UDI
Identifiers
- Catalog Number
- 200550N FDA UDI
- Primary DI / UDI-DI
- 00860013530228 FDA UDI
- 510(k) Number
- K153670 FDA UDI
- FDA Product Code
- QRL FDA UDI
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual blood lancing device, reusable
Genteel by Light Hill Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
Cleared under the same submission
K153670 also covers:
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
- Light Hill Medical Corporation
Sources (1)
- FDA UDI 8988cc4f-ed24-472c-bb3f-4bae80043d62 36 fields · synced Jun 1, 2026