Duns Number:690622428
Device Description: MANI Ophthalmic Sutures
Catalog Number
2020
Brand Name
MANI Sutures Silk
Version/Model Number
2020
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
GAP
Product Code Name
Suture, Nonabsorbable, Silk
Public Device Record Key
fae7165a-aee5-4e14-baa4-319dfb9fd900
Public Version Date
October 18, 2021
Public Version Number
7
DI Record Publish Date
June 04, 2016
Package DI Number
14546951402225
Quantity per Package
12
Contains DI Package
04546951402228
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 |