Identity
- Trade Name
- Surgicutt Bleeding Time Device FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Surgicutt Bleeding Time Device 50/box FDA UDI
- Model / Reference
- SU50I FDA UDI
- Description
- Surgicutt Bleeding Time Device 50/box FDA UDI
Identifiers
- Catalog Number
- SU50I FDA UDI
- Primary DI / UDI-DI
- 20711234304157 FDA UDI
- 510(k) Number
- K850542 FDA UDI
- FDA Product Code
- JCA FDA UDI
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6100 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 — 5.00 Millimeter FDA UDIDepth — 1.00 Millimeter FDA UDI
Surgicutt Bleeding Time 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 |
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Manufacturer
- Manufacturer
- Accriva Diagnostics Holdings, Inc.
Sources (1)
- FDA UDI ad5eb7cd-5641-420d-8761-4134950c8b1b 38 fields · synced May 30, 2026