Duns Number:068199363
Device Description: Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, Transpor Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, Transport Pad, Lubricating Jelly, and Gauze Pads.
Catalog Number
4005634
Brand Name
Custom Procedure Kit
Version/Model Number
4005634
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
f8ecca2c-ab89-464d-8eef-8b0c4db56cd0
Public Version Date
June 24, 2022
Public Version Number
1
DI Record Publish Date
June 16, 2022
Package DI Number
40677964027954
Quantity per Package
12
Contains DI Package
40677964027947
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 |