Identity
- Trade Name
- Unistik FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- Unistik Safety Lancet Economy - 21G FDA UDI
- Model / Reference
- AT 1015 FDA UDI
- Description
- Unistik Safety Lancet Economy - 21G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384701015014 FDA UDI
- FDA Product Code
- FMK FDA UDI
- GMDN Term
- Manual blood lancing device, single-use 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
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 21 Gauge FDA UDI
Category: Manual blood lancing device, single-use
Unistik by Owen Mumford Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, single-use.
- neoheel — Sterilance Medical (Suzhou) Inc. · Class II
- SurgiLance Lite Safety Lancet — MEDIPURPOSE PTE. LTD. · Class II
- AboutTime MPD 21Gx 1.8mm Safety Lancet — Medical Plastic Devices M.P.D. Inc · Class II
- EasyLife Pressure Activated Safety lancet 28G — CARE LIVING DIAGNOSTICS INC · Class II
- ONE-CARE OPTI Safety Lancets — MediVena, LLC · Class II
- GLUCO-CARE Safety Lancets 30G x 1.8 mm — MediVena, LLC · Class II
- STERiLANCE Press2 Disposable Safety Lancet — Sterilance Medical (Suzhou) Inc. · Class II
- neoheel — Sterilance Medical (Suzhou) Inc. · Class II
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
- Owen Mumford Limited
Sources (1)
- FDA UDI f8d2edec-e5e3-4a04-b012-eb265e7f743c 34 fields · synced Jun 1, 2026