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.B6105 model consists of a 6/0 Braided Silk suture of length 76cm attached with one 280 microns SS needles having the needle length of 8.0mm in both ends of suture. Angle of curvature of the needle is 135° [3/8 Circle]. Point profile of needle is Spatula.
Catalog Number
-
Brand Name
Aurosilk
Version/Model Number
B6105
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
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
GAP
Product Code Name
Suture, Nonabsorbable, Silk
Public Device Record Key
41d03295-5d3b-4f3a-9ce1-4dd3215eb7dd
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
June 23, 2020
Package DI Number
10803878029084
Quantity per Package
12
Contains DI Package
00803878029087
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |