Duns Number:600850213
Device Description: Biopsy, One Compartment, 0.9 x 0.9 mm, 45°, Lid Attached, Front Hinge, Gray, Sleeved
Catalog Number
-
Brand Name
Embedding Cassette
Version/Model Number
EC0204EXS
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
bb6cc4eb-e162-45ed-ae42-ced8ce53ecac
Public Version Date
May 27, 2022
Public Version Number
1
DI Record Publish Date
May 19, 2022
Package DI Number
10810050854518
Quantity per Package
750
Contains DI Package
00810050854511
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |