tangis - Instrument, Caddy Body 4 Level Plate, Anterior - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: Instrument, Caddy Body 4 Level Plate, Anterior Cervical Plating System (ACP)

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More Product Details

Catalog Number

-

Brand Name

tangis

Version/Model Number

ACP-CDY-104

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)

Yes

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

LRP

Product Code Name

Tray, Surgical

Device Record Status

Public Device Record Key

9a389f24-f605-434e-9f6b-a22bff119b75

Public Version Date

January 20, 2020

Public Version Number

4

DI Record Publish Date

February 28, 2017

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