Duns Number:021717889
Device Description: Compliance EndoKit
Catalog Number
CEK-2032
Brand Name
Compliance EndoKit™
Version/Model Number
CEK-2032
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
MNL
Product Code Name
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Public Device Record Key
56bea851-f7a2-46b7-8c56-ec8f887f130e
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
March 11, 2019
Package DI Number
08714729991946
Quantity per Package
20
Contains DI Package
08714729991939
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |