UNIFY PGA Surgical Sutures - UNIFY PGA Surgical Sutures, Absorbable, 5-0, 11mm - APPLIED DENTAL, INC.

Duns Number:017524666

Device Description: UNIFY PGA Surgical Sutures, Absorbable, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed

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More Product Details

Catalog Number

-

Brand Name

UNIFY PGA Surgical Sutures

Version/Model Number

XS-G518R11-U

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

K022664,K073614,K200392,K022664,K073614,K200392,K022664,K073614,K200392

Product Code Details

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Record Status

Public Device Record Key

27510389-a3f8-43a8-a82e-bcfc12b1f2f9

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Additional Identifiers

Package DI Number

10814639025511

Quantity per Package

12

Contains DI Package

00814639025514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"APPLIED DENTAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 121