Duns Number:012430880
Device Description: Steam Indicator Tape
Catalog Number
1048993
Brand Name
MAXITEST
Version/Model Number
1048993
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)
Yes
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
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
392f9ff5-556e-4800-bb6a-d21b12e1d01c
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10304040002480
Quantity per Package
36
Contains DI Package
00304040002483
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
ROLL
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |