Duns Number:809555139
Device Description: Barraquer Needle Holder, Standard, Straight shaft 10mm smooth jaws, Without Lock, Diamond Barraquer Needle Holder, Standard, Straight shaft 10mm smooth jaws, Without Lock, Diamond knurled handle, 135mm total length, Stainless Steel
Catalog Number
N14-S
Brand Name
Diamatrix
Version/Model Number
N14-S
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
-
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
ae195bca-e23c-499d-9a73-67fdbd786233
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
September 04, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 475 |
U | Unclassified | 13 |