Duns Number:080361159
Device Description: SLIDES, BEVELED EDGE, 3"X1"X1MM, DOUBLE FROSTED, 45 DEGREE CORNERS, 72/BX
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
MST204
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KEW
Product Code Name
Slides, Microscope
Public Device Record Key
f1932d36-f948-49da-a100-2bfadef38e43
Public Version Date
August 23, 2022
Public Version Number
1
DI Record Publish Date
August 15, 2022
Package DI Number
10840216100371
Quantity per Package
1440
Contains DI Package
00840216100374
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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |