SharpShooter® Surgical Suture - UHMWPE Suture for SharpShooter® - IVY SPORTS MEDICINE LLC

Duns Number:046226406

Device Description: UHMWPE Suture for SharpShooter®

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More Product Details

Catalog Number

HS4704

Brand Name

SharpShooter® Surgical Suture

Version/Model Number

HS4704

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2018

Issuing Agency

In HIBCC

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

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Device Record Status

Public Device Record Key

7431628a-1b2e-4405-8a47-f1f163a322f2

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

M928HS47042

Quantity per Package

10

Contains DI Package

M928HS47041

Package Discontinue Date

June 30, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton

"IVY SPORTS MEDICINE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6