Identity
- Trade Name
- MediHeel FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Button Activated Safety Heelstick Lancet FDA UDI
- Model / Reference
- 2005 FDA UDI
- Description
- Button Activated Safety Heelstick Lancet FDA UDI
Identifiers
- Catalog Number
- 2005 FDA UDI
- Primary DI / UDI-DI
- 10732671120059 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
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
Yes
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
- Depth — 1.0 Millimeter FDA UDI
MediHeel by Amity Holdings, Llc — 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
- Amity Holdings, Llc
Sources (1)
- FDA UDI 5139e3fd-72e4-4bb6-8c40-5d4784b6e42c 37 fields · synced May 30, 2026