Duns Number:830016148
Device Description: 3M™ Attest™ Steam Chemical Integrator with 2" Extender, 500/pack, 2 packs/case, 1243RES
Catalog Number
1243RES
Brand Name
3M™ Attest™
Version/Model Number
1243RES
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
K191236,K191236,K191236
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
61fbdbcb-00fe-48f8-a6be-cae5826e69c7
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 21, 2021
Package DI Number
50707387785760
Quantity per Package
2
Contains DI Package
30707387785766
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |