Releve GY1500/BX5

GUDID 00850000610156

Vaginal Support Device (Carton of 5)

SURGIN SURGICAL INSTRUMENTATION, INC.

Vaginal rectocele reduction instrument

• Primary Device ID: 00850000610156
• NIH Device Record Key: 4c16b2c5-d3d4-451e-b386-bad701b44fc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Releve
• Version Model Number: GY1500/BX5
• Catalog Number: GY1500/BX5
• Company DUNS: 076656164
• Company Name: SURGIN SURGICAL INSTRUMENTATION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000610156 [Primary]

FDA Product Code

• KOH: Instrument, Manual, General Obstetric-Gynecologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [Releve]

• 00850000610071: Intravaginal Support Device
• 00850000610156: Vaginal Support Device (Carton of 5)
• 00850000610088: Releve Protective Covers (30 pack)