Duns Number:315018218
Device Description: AESCULAP AICON Bottom, Standard 1/2, outer length: 300 mm, outer width: 297 mm, outer heig AESCULAP AICON Bottom, Standard 1/2, outer length: 300 mm, outer width: 297 mm, outer heigth: 136 mm, inner length: 250 mm, inner width: 258 mm, inner heigth: 114 mm
Catalog Number
JJ220
Brand Name
AICON
Version/Model Number
JJ220
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
637d170a-54b7-46f5-8fc6-7127d5d8b8d0
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 |