Duns Number:276593071
Device Description: CASE MCLS62SC SATALOFF
Catalog Number
MCLS62SC
Brand Name
MicroFrance®
Version/Model Number
MCLS62SC
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMO
Product Code Name
TRAY, SURGICAL, ENT
Public Device Record Key
0d6e2b56-6708-4ac7-8f56-7d6796fea7de
Public Version Date
September 16, 2022
Public Version Number
8
DI Record Publish Date
January 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1433 |
2 | A medical device with a moderate to high risk that requires special controls. | 879 |