Duns Number:106793995
Device Description: Cassette, Biopsy Embedding with Attached Lid, 30° Writing Area, ORANGE, 500/Dispenser Box, Cassette, Biopsy Embedding with Attached Lid, 30° Writing Area, ORANGE, 500/Dispenser Box, 2 Boxes/Unit
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
1091N
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
IDZ
Product Code Name
Cassettes, Tissue
Public Device Record Key
c7504b39-ea19-4398-9089-aa5a57d2bf60
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
November 27, 2019
Package DI Number
00840095600347
Quantity per Package
2
Contains DI Package
00840095600330
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 |