ULTRASOFT FRYDMAN® SET AVEC WIH GUIDE

Basic Information

• Brand Name: ULTRASOFT FRYDMAN® SET AVEC WIH GUIDE
• Primary DI: 03700111400443
• Version / Model: ULTRASOFT FRYDMAN® SET AVEC WIH GUIDE
• Catalog Number: 131230301
• Company Name: LABORATOIRE CCD
• Labeler DUNS: 381633924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-05
• Public Version: 1
• Public Version Date: 2023-12-13
• Public Version Status: New
• Public Device Record Key: be58e4e3-24b8-4c27-9cc5-264d5dc5cfc0

Device Description

03 pieces sets for embryo transfer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQF	CATHETER, ASSISTED REPRODUCTION	Obstetrics/Gynecology	884.6110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700111425446	GS1	Box	10	In Commercial Distribution
Primary	03700111400443	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.155	Centimeter
Catheter Length	26	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: -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.