nvc - Instrument, Rasp, Anterior Cervical Interbody - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)

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More Product Details

Catalog Number

-

Brand Name

nvc

Version/Model Number

AC-1214T-411

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HTR

Product Code Name

Rasp

Device Record Status

Public Device Record Key

d9695ccb-f520-4856-998d-77d6149fe68d

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

May 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NVISION BIOMEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 461
2 A medical device with a moderate to high risk that requires special controls. 1046