Duns Number:554479334
Device Description: Micromanipulation pipette is a disposable sterile product made of borosilicate glass for i Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-ICSI pipette is used to inject single sperm into oocytes.
Catalog Number
9201-30-7
Brand Name
DEWIN
Version/Model Number
D-ICSI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 31, 2023
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
f41596aa-0a06-48fd-b6e2-faf36997d8c5
Public Version Date
May 15, 2020
Public Version Number
1
DI Record Publish Date
May 07, 2020
Package DI Number
36972962310037
Quantity per Package
10
Contains DI Package
16972962310033
Package Discontinue Date
January 31, 2023
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |