Duns Number:025460908
Device Description: STRIP,STEAM INDICATOR,8",9BX/CS
Catalog Number
MDS200150C
Brand Name
Medline
Version/Model Number
MDS200150C
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRT
Product Code Name
INDICATOR, STERILIZATION
Public Device Record Key
3dbf5cca-4b8f-4064-a6b5-92088eeb164d
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
December 31, 2020
Package DI Number
20080196756992
Quantity per Package
250
Contains DI Package
40080196756996
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |