StarGuard Suture Retention Plates - 7" - For the temporary, external anchoring of sutures - PRESERVATION SOLUTIONS INC

Duns Number:090266979

Device Description: For the temporary, external anchoring of sutures and prevention of suture pull through.

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More Product Details

Catalog Number

-

Brand Name

StarGuard Suture Retention Plates - 7"

Version/Model Number

SG-7

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

Yes

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

KGS

Product Code Name

Retention Device, Suture

Device Record Status

Public Device Record Key

a035b6b7-ec56-40f2-b296-2fd306412737

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRESERVATION SOLUTIONS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 10