nvc

FDA UDI

Class I (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name: nvc FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF) FDA UDI
Model / Reference: AC-1416T-413 FDA UDI
Description: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF) FDA UDI

Identifiers

Primary DI / UDI-DI: 00814008023202 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 10 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI
Width — 16 Millimeter FDA UDI
Angle — 6 degree FDA UDI

Category: Bone file/rasp, manual, reusable

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

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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 I	Pending data

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Manufacturer

Manufacturer: Nvision Biomedical Technologies, Inc

Sources (1)

FDA UDI a81ea8ea-14fb-4413-b51a-e9f04078323e 35 fields · synced Jun 8, 2026