Duns Number:830016148
Device Description: 3M™ Attest™ Rapid 5 Steam-Plus Test Pack, 41382 for Steam Sterilization, 16 EA/BX
Catalog Number
41382
Brand Name
3M™ Attest™
Version/Model Number
41382
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)
-
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
d2edd2db-b9c2-4e41-9d9d-087e32cce409
Public Version Date
August 31, 2021
Public Version Number
1
DI Record Publish Date
August 23, 2021
Package DI Number
50707387787252
Quantity per Package
4
Contains DI Package
30707387787258
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
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 |