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Axis Implant ø6 L13mm

FDA UDI

Class II (US FDA UDI)

by T.a.g Medical Products Agricultural Cooperative Association

Identity

Trade Name
Axis Implant ø6 L13mm FDA UDI
Generic Name
Quetiapine IVD, reagent FDA UDI
Model / Reference
B FDA UDI

Identifiers

Catalog Number
IA1-60013 FDA UDI
Primary DI / UDI-DI
10810190010478 FDA UDI
510(k) Number
K143326 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Quetiapine IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 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

Yes

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Category: Quetiapine IVD, reagent

Axis Implant ø6 L13mm by T.a.g Medical Products Agricultural Cooperative Association — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K143326 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
T.a.g Medical Products Agricultural Cooperative Association

Sources (1)

  • FDA UDI ee2c53ac-f25f-4707-854d-7c4cc8b9c42a 34 fields · synced May 30, 2026