Golnit Nylon Monofilament Suture - Nylon Monofilament Non-absorbable Suture 30 inch - Golnit Sutures

Duns Number:079932697

Device Description: Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 5/0, Reverse Cutting Needl Nylon Monofilament Non-absorbable Suture 30 inch in length, USP 5/0, Reverse Cutting Needle, 16mm, 3/8 curvature, Sterile

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More Product Details

Catalog Number

-

Brand Name

Golnit Nylon Monofilament Suture

Version/Model Number

NB2D5016-75

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Device Record Status

Public Device Record Key

afd092ac-0d89-473b-9c77-bb27670b2c52

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GOLNIT SUTURES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7