Duns Number:536935331
Device Description: The silicone base is part of the container with reference 119985ND used in the transport a The silicone base is part of the container with reference 119985ND used in the transport and the sterilization of the associated instruments and non-sterile implants. It is composed of one base with two silicone bumpers to securely maintain the devices, one carpet with reference 119988ND and four wedges with reference 119909ND.The transport and sterilization containers are not intended to maintain sterility.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119986ND
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
8a919dd4-2f75-429f-8d38-4bf2ba17545a
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 |