Soviflex 1001

GUDID B79510011

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.

Birch Concepts LLC

Post-parturition vaginal retractor

• Primary Device ID: B79510011
• NIH Device Record Key: c7a75eff-530d-49a7-af89-62673ae75d73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soviflex
• Version Model Number: 1001
• Catalog Number: 1001
• Company DUNS: 042601599
• Company Name: Birch Concepts LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B79510010 [Primary]
HIBCC	B79510011 [Package]; Contains: B79510010; Package: Box [96 Units]; In Commercial Distribution
HIBCC	B79510012 [Package]; Contains: B79510010; Package: Box [24 Units]; In Commercial Distribution

FDA Product Code

• HDL: Retractor, Vaginal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-14
• Device Publish Date: 2022-09-06