Catalog Number
1052-6
Brand Name
ENDOTRIG
Version/Model Number
1052-6
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
NBH
Product Code Name
ACCESSORIES,ARTHROSCOPIC
Public Device Record Key
440f7706-ea0f-4d00-9deb-f135f80a1720
Public Version Date
September 02, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2020
Package DI Number
37613327364102
Quantity per Package
6
Contains DI Package
07613327364101
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2606 |
2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
3 | A medical device with high risk that requires premarket approval | 186 |