Duns Number:021056726
Device Description: Pinnacle 360°™ 25ga Microserrated™ Tewari Omnicep Forceps
Catalog Number
39.15.25PIN
Brand Name
Synergetics
Version/Model Number
39.15.25PIN
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
f6e2cd1e-84af-4b0c-9067-c54945f8e048
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 18, 2020
Package DI Number
20841305109104
Quantity per Package
5
Contains DI Package
10841305102627
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 336 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |