Duns Number:081277700
Device Description: University of Texas 22 Instrument Cassette with One Color Color Code Rack
Catalog Number
3118122UTX
Brand Name
Integra® Miltex®
Version/Model Number
3118122UTX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 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)
Yes
Over the Counter (OTC)
-
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
ee84b3e1-f43e-4bf4-aef3-fc6bf6952184
Public Version Date
August 03, 2022
Public Version Number
6
DI Record Publish Date
August 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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |