Duns Number:315018218
Device Description: PRIMELINE Lid (Outer), Standard 3/4, grey, outer length: 463 mm, outer width: 285 mm, oute PRIMELINE Lid (Outer), Standard 3/4, grey, outer length: 463 mm, outer width: 285 mm, outer heigth: 46 mm
Catalog Number
JP015
Brand Name
AESCULAP
Version/Model Number
JP015
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 2022
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
c9cbd7f3-0e9c-4726-b307-9c2e29963e20
Public Version Date
January 19, 2022
Public Version Number
6
DI Record Publish Date
September 23, 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 |