AccessGUDID - DEVICE: CLASSIC ULTRASOFT 18 CM (03700111400108)

GUDID

Device Identifier (DI) Information

Brand Name: CLASSIC ULTRASOFT 18 CM
Version or Model: CLASSIC ULTRASOFT 18 CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1321301
Company Name: LABORATOIRE CCD

Primary DI Number: 03700111400108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381633924 *Terms of Use

Device Description: 02 pieces sets for embryo transfer

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
30882	Assisted reproduction transfer catheter trial	A flexible polymer tube intended to be used to simulate the transvaginal insertion of an assisted reproduction catheter set for embryo transfer, to assess advancement through the cervical canal and the position of the uterus. It typically consists of an inner and outer catheter (or catheter sheath) identical to the devices used for the transfer procedure, except that the inner catheter has a rounded blind/closed distal end. This device cannot be used for the introduction of embryos or other reproductive materials into the cervical canal or uterine cavity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQF	CATHETER, ASSISTED REPRODUCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 24.4 Centimeter
Outer Diameter: 0.155 Centimeter

Device Record Status

Public Device Record Key: 9bec8c5a-9bd2-4d5b-8f40-afcb0cbaee5d
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023