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.B4401 model consists of a 4/0 Braided Silk suture of length 76cm attached with one 430 microns SS needles having the needle length of 15.9mm in both ends of suture. Angle of curvature of the needle is 135° [3/8 Circle]. Point profile of needle is Conventional cutting.

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More Product Details

Catalog Number

-

Brand Name

Aurosilk

Version/Model Number

B4401

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

d1270ca3-829a-4bd4-8f91-105154daf7a1

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2020

Additional Identifiers

Package DI Number

10803878029077

Quantity per Package

12

Contains DI Package

00803878029070

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