Duns Number:085668598
Device Description: Koch Salz Nucleus Splitting Fcps, Titan.
Catalog Number
05-2351
Brand Name
Oph.Forceps
Version/Model Number
05-2351
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
88990abf-0078-41b1-839a-5d49ea484f3c
Public Version Date
March 18, 2021
Public Version Number
2
DI Record Publish Date
September 14, 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 | 1518 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| U | Unclassified | 63 |