Duns Number:830016148
Device Description: 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V
Catalog Number
41482V
Brand Name
3M™ Attest™
Version/Model Number
41482V
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
afdda54c-8b63-41a4-b220-62d6cc97240e
Public Version Date
July 07, 2020
Public Version Number
1
DI Record Publish Date
June 29, 2020
Package DI Number
50707387787276
Quantity per Package
2
Contains DI Package
30707387787272
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |