Duns Number:315018218
Device Description: AESCULAP AICON Bottom, with EDS, Standard 1/1, outer length: 598 mm, outer width: 297 mm, AESCULAP AICON Bottom, with EDS, Standard 1/1, outer length: 598 mm, outer width: 297 mm, outer heigth: 186 mm, inner length: 548 mm, inner width: 258 mm, inner heigth: 164 mm
Catalog Number
JJ131
Brand Name
AICON
Version/Model Number
JJ131
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
ad2b9c21-e568-47ee-9dee-7fabdfd20e6c
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
November 28, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |