Avalign - K-Style Crank Frame Retractor Body, OL 180mm (7 - AVALIGN TECHNOLOGIES, INC.

Duns Number:792528510

Device Description: K-Style Crank Frame Retractor Body, OL 180mm (7 1/8”)

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More Product Details

Catalog Number

-

Brand Name

Avalign

Version/Model Number

VM84-9213

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

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Device Record Status

Public Device Record Key

a69f7f26-d037-4187-bfcc-bf223fc181af

Public Version Date

October 21, 2019

Public Version Number

1

DI Record Publish Date

October 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVALIGN TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6832
2 A medical device with a moderate to high risk that requires special controls. 9482