Duns Number:106793995
Device Description: Microscope Cover Glass, 22mm x 60mm, # 2 Thickness, 1 oz./Vacuum Pack, 10 Packs/Box (10 oz Microscope Cover Glass, 22mm x 60mm, # 2 Thickness, 1 oz./Vacuum Pack, 10 Packs/Box (10 oz.)
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
1418-20
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
KES
Product Code Name
Coverslips, Microscope Slide
Public Device Record Key
b68bb37b-49d6-4dc4-a69d-07b8d80f57cd
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
November 26, 2019
Package DI Number
00840095604307
Quantity per Package
20
Contains DI Package
00840095604291
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 | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |