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Tecomet

FDA UDI

Class I (US FDA UDI)

by Tecomet, Inc

Identity

Trade Name
Tecomet FDA UDI
Generic Name
Surgical implant template, reusable FDA UDI
Device Name
T-ROD, 5.0mm SIL COVERED ANDZ ALUM FDA UDI
Model / Reference
AZA032200 FDA UDI
Description
T-ROD, 5.0mm SIL COVERED ANDZ ALUM FDA UDI

Identifiers

Primary DI / UDI-DI
00841379140559 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Surgical implant template, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

Tecomet by Tecomet, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant template, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tecomet, Inc

Sources (1)

  • FDA UDI 00283b9e-ab9f-44dc-a11d-81e4e2a09dc5 33 fields · synced Sep 18, 2026