UNIFY Nylon Surgical Sutures - Nylon Suture, 5-0, 13mm 3/8 circle Rev Cut, 18" 3 - APPLIED DENTAL, INC.

Duns Number:017524666

Device Description: Nylon Suture, 5-0, 13mm 3/8 circle Rev Cut, 18" 3 DZN Pack

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More Product Details

Catalog Number

-

Brand Name

UNIFY Nylon Surgical Sutures

Version/Model Number

S-N518XR13

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Device Record Status

Public Device Record Key

1add63b2-cbe7-46c5-becf-796b339192db

Public Version Date

May 05, 2021

Public Version Number

1

DI Record Publish Date

April 27, 2021

Additional Identifiers

Package DI Number

10814639025658

Quantity per Package

36

Contains DI Package

00814639025651

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