Duns Number:801895244
Device Description: Origio, Inc. 5.75" (14.6 cm) Cotton Plugged IVF Pasteur Pipets
Catalog Number
-
Brand Name
Cotton Plugged IVF Pasteur Pipets
Version/Model Number
PP-5.75-1000PL
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
K000915,K000915
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
097807c1-04d5-4e05-81ee-17c6df2f9ddb
Public Version Date
November 08, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20888937014062
Quantity per Package
20
Contains DI Package
50888937014063
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |