Duns Number:068199363
Device Description: Endo Carry-on Procedure Kit includes Basin, Cylindrical Sponge, Bedside Concentrate, BioGu Endo Carry-on Procedure Kit includes Basin, Cylindrical Sponge, Bedside Concentrate, BioGuard Air Water Cleaning Adapter, Transport Pad, Lube Tube, Gauze Pads, and Intercept Detergent.
Catalog Number
4006273
Brand Name
Endo-Carry-on Procedure Kit
Version/Model Number
4006273
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
e55a2611-eb81-4759-aaa6-c47d91867706
Public Version Date
October 25, 2022
Public Version Number
1
DI Record Publish Date
October 17, 2022
Package DI Number
40677964034136
Quantity per Package
14
Contains DI Package
40677964034129
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 |