SImmetry® - SIJ Washer For Use with SImmetry® SIJ Implant - ZYGA TECHNOLOGY, INC.

Duns Number:024049072

Device Description: SIJ Washer For Use with SImmetry® SIJ Implant 14.5mm

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More Product Details

Catalog Number

10-W14500-01

Brand Name

SImmetry®

Version/Model Number

10-W14500-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 28, 2020

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

Yes

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

OUR

Product Code Name

Sacroiliac Joint Fixation

Device Record Status

Public Device Record Key

a0c13048-08c4-4d6d-a495-034417c4d832

Public Version Date

April 09, 2021

Public Version Number

4

DI Record Publish Date

October 15, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZYGA TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 41