Duns Number:830016148
Device Description: 3M™ Comply™ Glutaraldehyde Monitor 1.8% 3987
Catalog Number
3987
Brand Name
Comply™
Version/Model Number
3987
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
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
9d0b9434-7e0f-47c9-99d8-3c10def95cfa
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50707387469554
Quantity per Package
2
Contains DI Package
00707387469559
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 |