Gynosampler

Basic Information

• Brand Name: Gynosampler
• Primary DI: 10805360016831
• Version / Model: 15099
• Company Name: VITROLIFE INC.
• Labeler DUNS: 051915038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2020-04-29
• Public Version Status: Update
• Public Device Record Key: dd73f40b-02a8-49bf-8b4d-6c05b3a99dcf
• Distribution End Date: 2020-04-28

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
HFF	Aspirator, Endometrial	Obstetrics/Gynecology	884.1060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11531	Endometrial biopsy kit	A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10805360016831	GS1
Unit of Use	00008053606835	GS1