Duns Number:241975256
Device Description: A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, de A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures.The Biopsy Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to aspirate or remove blastomere(s) from a developing embryo for pre-implantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Intended for one-time use.
Catalog Number
-
Brand Name
MICROTOOLS (Biopsy Pipette)
Version/Model Number
B-35FP04
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
K102480,K102480
Product Code
MQH
Product Code Name
Microtools, Assisted Reproduction (Pipettes)
Public Device Record Key
15891aab-07c6-4de6-877b-5dfb69f8953a
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 07, 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. | 45 |