SPIRETTE®

Basic Information

• Brand Name: SPIRETTE®
• Primary DI: 03700111400733
• Version / Model: SPIRETTE®
• Catalog Number: 1106000
• 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: cc633836-3d14-4e89-9d69-6261e3bcbf47

Device Description

Device for cervical mucus aspiration

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
HDR	CAP, CERVICAL	Obstetrics/Gynecology	884.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47070	Cervical aspiration catheter	A semi-rigid, sterile, tube designed to aspirate cervical mucous, typically for the evaluation of infertility. It is used to obtain cervical mucous samples for post-coital determination of spermatic hostility; it may also be used to remove a viscous mucous barrier prior to intrauterine insemination, embryo transfer, or other transcervical procedures. The tube usually contains a rigid inner tube with a plunger that is positioned near the distal end; once in situ, the plunger is slowly withdrawn, creating a suction that draws mucous into the tube. The mucous is typically expelled onto a microscope slide for examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700111425736	GS1	Box	25	In Commercial Distribution
Primary	03700111400733	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.26	Centimeter
Catheter Length	26.4	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.