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 needleand Nylon suture.8482N model consists of a 8/0 Nylon suture of length 40cm attached with two 200 microns SS needles having the needle length of 6.0mm in both theends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Spatula.
Catalog Number
-
Brand Name
Aurolon
Version/Model Number
8482N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K024090,K024090
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
6fb6b0c6-acb9-4f1f-bc28-e2d9794179e7
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
June 20, 2020
Package DI Number
10803878028926
Quantity per Package
12
Contains DI Package
00803878028929
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 |