Identity
- Trade Name
- Dario 100 Sterile Lancets FDA UDI
- Generic Name
- Blood lancing device tip FDA UDI
- Device Name
- The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancing device cover prevents the user from unintentional punctures. FDA UDI
- Model / Reference
- 1121-05 FDA UDI
- Description
- The disposable Dario 100 Sterile Lancets pack is intended for use with Dario Blood Glucose Monitoring Systems. The orange lancing device cover prevents the user from unintentional punctures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850065006222 FDA UDI
- FDA Product Code
- FMK FDA UDI
- GMDN Term
- Blood lancing device tip 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancing device tip
Dario 100 Sterile Lancets by Labstyle Innovation Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Labstyle Innovation Ltd
Sources (1)
- FDA UDI ad881d90-bd33-48a1-a801-d6ed6d72a672 33 fields · synced May 30, 2026