Duns Number:283088573
Device Description: Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Catalog Number
-
Brand Name
Follicle Aspiration needle - single lumen
Version/Model Number
#4551 FAS XD-BCB2
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
K013497,K013497,K013497
Product Code
MQE
Product Code Name
Needle, Assisted Reproduction
Public Device Record Key
056c5d04-d074-49b0-ad70-6da00519a83e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
November 03, 2016
Package DI Number
25425017505840
Quantity per Package
50
Contains DI Package
05425017505846
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |