Duns Number:315018218
Device Description: Bottom, with base perforation, Size XXL, outer length: 711 mm, outer width: 265 mm, outer Bottom, with base perforation, Size XXL, outer length: 711 mm, outer width: 265 mm, outer heigth: 187 mm, inner length: 544 mm, inner width: 258 mm, inner heigth: 232 mm
Catalog Number
JN445
Brand Name
AESCULAP
Version/Model Number
JN445
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
FLE
Product Code Name
Sterilizer, steam
Public Device Record Key
05a61e2d-5f79-4a0b-bfb2-b3a43a82e16f
Public Version Date
July 08, 2021
Public Version Number
9
DI Record Publish Date
September 30, 2016
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 |