Releve

Basic Information

• Brand Name: Releve
• Primary DI: 00850000610071
• Version / Model: GY1500
• Catalog Number: GY1500
• Company Name: SURGIN SURGICAL INSTRUMENTATION, INC.
• Labeler DUNS: 076656164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-15
• Public Version: 1
• Public Version Date: 2023-07-24
• Public Version Status: New
• Public Device Record Key: 2d83d85b-86be-4a31-b085-065d28c58d0f

Device Description

Intravaginal Support Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58727	Vaginal rectocele reduction instrument	A non-sterile, hand-held, retractor-like device intended to be used to manually reduce a rectocele (herniation of lower bowel/rectum through a vaginal wall tear) during defecation to facilitate bowel emptying. It is intended to be used by direct application into the vagina by the patient during routine self-treatment to replace digital reduction and as an alternative to the more permanent pessary or surgical repair. It is typically made of plastic material and can be reused after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850000610071	GS1