Duns Number:068199363
Device Description: Custom Procedure Kit includes Basin, Sponge, Air Water Cleaning Adapter, Transport Pad, Lu Custom Procedure Kit includes Basin, Sponge, Air Water Cleaning Adapter, Transport Pad, Lubricating Jelly, Gauze, and Suction Tubing.
Catalog Number
4005608
Brand Name
Custom Procedure Kit
Version/Model Number
4005608
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
b6b64e22-9954-430c-803d-21440c39a447
Public Version Date
June 24, 2022
Public Version Number
1
DI Record Publish Date
June 16, 2022
Package DI Number
40677964027879
Quantity per Package
20
Contains DI Package
40677964027862
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 |