Duns Number:190094230
Device Description: InVitroCare's Polyvinylpyrrolidone (PVP) reagent is composed of polyvinylpyrrolidone (MW:3 InVitroCare's Polyvinylpyrrolidone (PVP) reagent is composed of polyvinylpyrrolidone (MW:360,000) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. PVP is intended for use as a medium for the immobilization and isolation of single sperm cells during intracytoplasmic sperm injection (ICSI) procedures.
Catalog Number
2210
Brand Name
PVP - Polyvinylpyrrolidone
Version/Model Number
2210
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
K001967
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
1426838e-9397-470c-a8e6-66c64b7b60bd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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. | 29 |