AccessGUDID - DEVICE: Embryo transfer catheter (05425017501312)

GUDID

Device Identifier (DI) Information

Brand Name: Embryo transfer catheter
Version or Model: #4000 The Tulip
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gynetics Medical Products NV

Primary DI Number: 05425017501312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283088573 *Terms of Use

Device Description: Embryo transfer catheter used for introduction of embryos into the uterine cavity.

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?
41438	Assisted reproduction catheter set	A collection of sterile devices used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MQF	Catheter, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013536	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
Total Volume: 0.21 Milliliter

Device Record Status

Public Device Record Key: 2ea35c79-d0a1-4508-aaf7-07f673c6082e
Public Version Date: August 31, 2018
Public Version Number: 5
DI Record Publish Date: October 14, 2016