Duns Number:068199363
Device Description: Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Tra Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, Suction Tube, Gauze, Double-Header Channel Brush, Gown, and Biohazard Sticker.
Catalog Number
4006148
Brand Name
Endo-Carry-on Procedure Kit
Version/Model Number
4006148
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
7524b6ae-11f0-4610-8781-b073d9933eec
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
Package DI Number
40677964033177
Quantity per Package
12
Contains DI Package
40677964033160
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 |