Duns Number:947451626
Device Description: Tyvek Roll with Sterrad Chemical Indicator 200 mm x 70 m
Catalog Number
12420
Brand Name
Tyvek Roll
Version/Model Number
12420
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
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
K103210,K112087,K141693,K103210,K112087,K141693
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
1e23189e-8f00-4943-b497-1bbde9e66f58
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20705037015822
Quantity per Package
4
Contains DI Package
10705037015825
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 159 |