Aurosilk - Non absorbable Ophthalmic Suture Needle is an - AUROLAB

Duns Number:677319965

Device Description: Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Braided Silk suture.8481S model consists of a 8/0 Braided Silk suture of length 15cm attached with one 200 microns SS needles having the needle length of 6.0mm in oneend of suture. Angle of curvature of the needle is 140° [3/8 Circle]. Point profile of needle is Spatula.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Aurosilk

Version/Model Number

8481S

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

K024091,K024091

Product Code Details

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Device Record Status

Public Device Record Key

9d3d411a-0d36-462c-a05a-9ac0082c1a9a

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2020

Additional Identifiers

Package DI Number

10803878028902

Quantity per Package

12

Contains DI Package

00803878028905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"AUROLAB" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 17