Duns Number:536935331
Device Description: The midfoot implant container is used in the transport and the sterilization of the non s The midfoot implant container is used in the transport and the sterilization of the non sterile implants and their associated instruments. It includes one base with reference 188212ND, one screw rack with reference 188216ND, one lid with reference 996200ND and one carpet with reference 188219ND.The transport and sterilization containers are not intended to maintain sterility.
Catalog Number
-
Brand Name
ADVANSYS®
Version/Model Number
188202ND
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
780a1e99-0ed3-4e57-9916-f45ea32055c1
Public Version Date
July 08, 2021
Public Version Number
5
DI Record Publish Date
May 26, 2017
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |