AccessGUDID - DEVICE: Follicle Aspiration needle

GUDID

Device Identifier (DI) Information

Brand Name: Follicle Aspiration needle - single lumen
Version or Model: #4551 FAS XD-BCB2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gynetics Medical Products NV

Primary DI Number: 05425017505846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283088573 *Terms of Use

Device Description: Transvaginal harvesting of oocytes from follicles for IVF and ICSI.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45676	IVF oocyte aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQE	Needle, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013497	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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