Duns Number:080284658
Device Description: 3 Piece Tray Cover Pack - 1 - 24” X 28” Clear, 1 - 24” X 28” Red, 1 - 34” X 30” Clear (TC3 3 Piece Tray Cover Pack - 1 - 24” X 28” Clear, 1 - 24” X 28” Red, 1 - 34” X 30” Clear (TC3B) Non-Sterile
Catalog Number
-
Brand Name
Sterimed
Version/Model Number
TC3B
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
Yes
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
IZI
Product Code Name
System, X-Ray, Angiographic
Public Device Record Key
11668484-23ad-4bff-81cb-8685e8f40bbc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 18, 2017
Package DI Number
10867878000443
Quantity per Package
500
Contains DI Package
00867878000446
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 108 |