Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each

Basic Information

• Brand Name: Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each
• Primary DI: 57290018240019
• Version / Model: 01
• Catalog Number: IL-100-200-500
• Company Name: ILLUMIGYN LTD
• Labeler DUNS: 600627621
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 8f1f1e95-a001-4ef7-85a5-525151a7a454

Device Description

20 units with small size 20 units with medium size 20 units with lager size. Indications for Use Gynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope system.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64926	Video colposcope speculum	A hand-held manual instrument, into which a video colposcope camera unit is placed, intended to dilate the vagina after insertion for visual examination of the tissues of the vagina, cervix, and external genitalia. It consists of two blades which can be opened at the distal end, and a cradle for attaching the camera in the handle-like proximal end; the camera is connected to a video colposcope camera/monitor (not included). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	57290018240019	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 40 Degrees Celsius