Duns Number:002348191
Device Description: GABBAY-FRATER SUTORGANIZER (4 PIECES OF 1)
Catalog Number
GFS-1A
Brand Name
DEKNATEL
Version/Model Number
IPN912380
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"
Yes
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
6fb422ea-6c77-466d-87f7-1db8d175316e
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
August 01, 2018
Package DI Number
04026704626700
Quantity per Package
4
Contains DI Package
14026704626707
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sleeve
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |