Duns Number:315018218
Device Description: Bottom, without base perforation, Standard 1/1, outer length: 592 mm, outer width: 274 mm, Bottom, without base perforation, Standard 1/1, outer length: 592 mm, outer width: 274 mm, outer heigth: 120 mm, inner length: 544 mm, inner width: 258 mm, inner heigth: 105 mm
Catalog Number
XG397
Brand Name
AESCULAP
Version/Model Number
XG397
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2020
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
50bc1441-589a-4cd8-9e5b-b2961eac582f
Public Version Date
October 27, 2021
Public Version Number
11
DI Record Publish Date
October 10, 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 |