Duns Number:830016148
Device Description: 3M™ ESPE™ Attest™ Biological Indicators for 270°F/132°C Gravity Displacement Steam Sterili 3M™ ESPE™ Attest™ Biological Indicators for 270°F/132°C Gravity Displacement Steam Sterilizers, 1261P
Catalog Number
1261P
Brand Name
Attest™
Version/Model Number
1261P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 27, 2023
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
-
Product Code
FRC
Product Code Name
Indicator, biological sterilization process
Public Device Record Key
53996476-1a62-4192-a2e9-964ceda43819
Public Version Date
March 17, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50605861032419
Quantity per Package
4
Contains DI Package
30605861032415
Package Discontinue Date
April 27, 2023
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 |