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-HOLD pipette is used to hold an oocyte or embryo during micromanipulation procedure.
Catalog Number
9203-30-7
Brand Name
DEWIN
Version/Model Number
D-HOLD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 28, 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
9e1d5a22-4fa3-4c92-8e97-6f530a6f77e6
Public Version Date
May 15, 2020
Public Version Number
1
DI Record Publish Date
May 07, 2020
Package DI Number
36972962310150
Quantity per Package
10
Contains DI Package
16972962310156
Package Discontinue Date
February 28, 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 |