Duns Number:047644935
Device Description: Outer Container Only (for TMR Blades and Ratchets/Clamps)
Catalog Number
72153-a
Brand Name
Trays
Version/Model Number
72153-a
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102146
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
8d379d92-69e7-4350-ad5a-d4ae63d47bce
Public Version Date
July 08, 2021
Public Version Number
6
DI Record Publish Date
September 17, 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 | 882 |
2 | A medical device with a moderate to high risk that requires special controls. | 595 |