Duns Number:342250668
Device Description: V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipet V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET pipettes for the manipulation of cells with the help of a micromanipulator. For intracytoplasmic injection (ICSI) of a single sperm into the oocyte (with and without spike).
Catalog Number
V-INJ-S3-35
Brand Name
V-ICSIPET INJECTION
Version/Model Number
V-ICSIPET Injection with Spike 35
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUC
Product Code Name
Microtools, Assisted Reproduction (Pipettes), Exempt
Public Device Record Key
6bfc3aa6-9954-4e46-a32d-989c674fbb43
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |