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GLUCOPAD TC-SMART+ Lancets Kit

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

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 50 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 50 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
10673486002461 FDA UDI
510(k) Number
K220475 FDA UDI
FDA Product Code
QRL FDA UDI
QRK 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

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

GLUCOPAD TC-SMART+ Lancets Kit by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K220475 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI 0b6a5918-1cb5-4aa0-a344-950c0b1f1926 37 fields · synced May 31, 2026