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 needle and PGA suture.A5108 model consists of a 5/0 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
A5108
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)
-
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,K140039
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
0a6cfed5-0ebd-4a3d-88ab-7f03a6c25670
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
December 12, 2020
Package DI Number
10803878041635
Quantity per Package
12
Contains DI Package
00803878041638
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 |