Duns Number:830016148
Device Description: 3M™ Attest™ Super Rapid Readout Biological Indicator 1492VS, for Steam Sterilization, 50 E 3M™ Attest™ Super Rapid Readout Biological Indicator 1492VS, for Steam Sterilization, 50 Each/Carton, 2 Cartons/Case
Catalog Number
1492VS
Brand Name
3M™ Attest™
Version/Model Number
1492VS
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
K173437,K173437,K173437
Product Code
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
9e0f4136-42cf-4126-bb10-1af6a61e1db8
Public Version Date
July 20, 2020
Public Version Number
1
DI Record Publish Date
July 10, 2020
Package DI Number
50707387791914
Quantity per Package
2
Contains DI Package
30707387791910
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 |