VariLock 03401

GUDID 00859500005073

VariLock Balloon Inflation Syringe, Bulk Sterile

FEMASYS INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00859500005073
• NIH Device Record Key: 66b3703f-b182-4ac4-9506-ece48ee3d1c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariLock
• Version Model Number: VL-1001
• Catalog Number: 03401
• Company DUNS: 147590330
• Company Name: FEMASYS 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
GS1	00859500005073 [Primary]

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

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: 2023-06-14
• Device Publish Date: 2023-06-06

On-Brand Devices [VariLock]

• 00859500005073: VariLock Balloon Inflation Syringe, Bulk Sterile
• 00859500005127: VariLock Balloon Inflation Syringe 3mL, Bulk Sterile