Duns Number:068199363
Device Description: Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, DEFENDO Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, DEFENDO Biopsy Valve, Olympus and Fujifilm, Lubricating Jelly, Transport Pad, Gauze pad, Suction tube, Gown, Slip no- sterile Syringe, Back Flow Valve and Biohazard Sticker
Catalog Number
4005476
Brand Name
Custom Procedure Kit
Version/Model Number
4005476
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
54716bd3-2b77-43bc-a901-dd01919f6d6c
Public Version Date
June 24, 2022
Public Version Number
1
DI Record Publish Date
June 16, 2022
Package DI Number
40677964027664
Quantity per Package
6
Contains DI Package
40677964027657
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 |