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.N7202 model consists of a 7/0 Nylon suture of length 30cm attached with two 230 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 Taper point.
Catalog Number
-
Brand Name
Aurolon
Version/Model Number
N7202
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
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
d9c8926f-2a11-4294-8ff9-a047650dccdb
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
June 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |