Duns Number:068199363
Device Description: Endo Carry-on Procedure Kit includes Basin, Intercept Detergent, Flat Sponge, and Lubricat Endo Carry-on Procedure Kit includes Basin, Intercept Detergent, Flat Sponge, and Lubricating Jelly.
Catalog Number
4006222
Brand Name
Endo-Carry-on Procedure Kit
Version/Model Number
4006222
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
NWU
Product Code Name
Endoscope introducer kit
Public Device Record Key
6057c442-c87c-4707-95b5-7378bc464990
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
Package DI Number
40677964033634
Quantity per Package
16
Contains DI Package
40677964033627
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 | 2999 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 362 |