Identity
- Trade Name
- microdot® FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- 28g /1.8mm Pressure Activated Safety Lancet (Box of 200 lancets) FDA UDI
- Model / Reference
- 528-28 FDA UDI
- Description
- 28g /1.8mm Pressure Activated Safety Lancet (Box of 200 lancets) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847713000084 FDA UDI
- 510(k) Number
- K222376 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
- 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
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
Yes
FDA UDI
Category: Blood lancet, single-use
microdot® by Cambridge Sensors USA, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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Cleared under the same submission
K222376 also covers:
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- VacSure EZ Care Pressure Activate Safety Lancet — LABOTEK GROUP CORP
- VacSure EZ Care Pressure Activate Safety Lancet — LABOTEK GROUP CORP
- EasyTouch — MHC Medical Products
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
- Cambridge Sensors USA, LLC.
Sources (1)
- FDA UDI e7b97b99-0c81-406c-b0ae-ba80ec6b52e5 34 fields · synced May 30, 2026