Duns Number:876570990
Device Description: Castroviejo suturing forceps, straight shafts, 0.12mm 1x2 teeth, 5.5mm tying platforms, wi Castroviejo suturing forceps, straight shafts, 0.12mm 1x2 teeth, 5.5mm tying platforms, wide serrated handle, titanium
Catalog Number
-
Brand Name
Medetz Surgical Instruments
Version/Model Number
11-0685t
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
e1445418-425a-4a99-83b8-9411cefc4ab7
Public Version Date
March 04, 2022
Public Version Number
1
DI Record Publish Date
February 24, 2022
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 | 120 |