Duns Number:216745893
Device Description: AEC120 Size 2 (L) Endocuff Sterile Green- 1 pot - single unit
Catalog Number
-
Brand Name
Endocuff
Version/Model Number
AEC120
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"
Yes
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
K122565,K122565,K122565
Product Code
FED
Product Code Name
Endoscopic Access Overtube, Gastroenterology-Urology
Public Device Record Key
4b62fc06-2cce-4d34-a557-a4474dd27e62
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 08, 2016
Package DI Number
5060423410010
Quantity per Package
8
Contains DI Package
05060423410096
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |