Duns Number:530269083
Device Description: PE coated, Alligator tooth, 2.3*2300mm
Catalog Number
NGF13-11023230
Brand Name
NA
Version/Model Number
NGF13-11023230
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
OCZ
Product Code Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Public Device Record Key
6974752f-bf7c-46d1-b059-a7cb6aa8bf7c
Public Version Date
May 17, 2021
Public Version Number
4
DI Record Publish Date
March 11, 2016
Package DI Number
36932503561045
Quantity per Package
20
Contains DI Package
26932503561048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
transport case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 142 |