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tangis

FDA UDI

Class I (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name
tangis FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Instrument, Drill 12mm, Anterior Cervical Plating System (ACP) FDA UDI
Model / Reference
ACP-DRL-12 FDA UDI
Description
Instrument, Drill 12mm, Anterior Cervical Plating System (ACP) FDA UDI

Identifiers

Primary DI / UDI-DI
00814008025619 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

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

Dimensions & Sizes

Size
Depth — 12 Millimeter FDA UDI

Category: General internal orthopaedic fixation system implantation kit

tangis by Nvision Biomedical Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nvision Biomedical Technologies, Inc

Sources (1)

  • FDA UDI ebb6c739-43d6-436e-acaa-5108f34151c3 35 fields · synced May 31, 2026