Identity
- Trade Name
- GLUCOPAD TC-SMART+ Lancets Kit FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Each GLUCOPAD TC-SMART+ Lancets Kit has 100 pcs per kit. The intended use is for capillary blood sampling on a patient age 6 months and up. Lancet is for single use only. FDA UDI
- Model / Reference
- G852-E-001 FDA UDI
- Description
- Each GLUCOPAD TC-SMART+ Lancets Kit has 100 pcs per kit. The intended use is for capillary blood sampling on a patient age 6 months and up. Lancet is for single use only. FDA UDI
Identifiers
- Catalog Number
- G852-E-001 FDA UDI
- Primary DI / UDI-DI
- 10673486002478 FDA UDI
- 510(k) Number
- K220475 FDA UDI
- FDA Product Code
- QRL FDA UDIQRK 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
Yes
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
GLUCOPAD TC-SMART+ Lancets Kit by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220475 also covers:
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
- Teco Diagnostics
Sources (1)
- FDA UDI 966120af-64dc-498e-af58-e616bfe10b17 36 fields · synced May 30, 2026