Duns Number:690622428
Device Description: MANI Ophthalmic Sutures
Catalog Number
2000
Brand Name
MANI Sutures Nylon
Version/Model Number
2000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
2f2ac138-7fe0-4635-b8f4-0376608932bb
Public Version Date
October 18, 2021
Public Version Number
8
DI Record Publish Date
June 04, 2016
Package DI Number
14546951401860
Quantity per Package
12
Contains DI Package
04546951401863
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1000 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |