Duns Number:809555139
Device Description: Castroviejo Suturing Forceps, .12mm very delicate 1x2 teeth, 5.5mm tying platform, Straigh Castroviejo Suturing Forceps, .12mm very delicate 1x2 teeth, 5.5mm tying platform, Straight shafts, Flat serrated handle with lateral grooves, 109mm total length, Titanium
Catalog Number
301T.12
Brand Name
Diamatrix
Version/Model Number
F301T.12
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
8c87160a-0440-4950-992f-703d094f5701
Public Version Date
October 29, 2020
Public Version Number
1
DI Record Publish Date
October 21, 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 |