Bookwalter-Gordon™ - Adjustable Compression Element, In Sterilization - SYMMETRY SURGICAL INC.

Duns Number:079641356

Device Description: Adjustable Compression Element, In Sterilization Case

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More Product Details

Catalog Number

50-5769

Brand Name

Bookwalter-Gordon™

Version/Model Number

50-5769

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 9999

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

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

4ca3813b-e481-4494-9b88-9addbe65ad14

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

June 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYMMETRY SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7981
2 A medical device with a moderate to high risk that requires special controls. 3309