Duns Number:677319965
Device Description: Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stai Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needleand PGA suture.A6108 model consists of a 6/0 PGA suture of length 45cm attached with two 330 microns SS needles having the needle length of 8.0mm in both theends of suture. Angle of curvature of both the needles are 90° [1/4 Circle]. Point profile of both needles are Spatula.
Catalog Number
-
Brand Name
Polycryl
Version/Model Number
A6108
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
K140039
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
d4092b30-caf6-4ccc-b6ec-2e4fa1b81597
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
September 16, 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 |