StopLock 04391

GUDID 00859500005165

StopLock Balloon Inflation Syringe 5-Pack, SLK-100

FEMASYS INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00859500005165
• NIH Device Record Key: 8e24d59b-e015-460f-b1b9-114cf02b6fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StopLock
• Version Model Number: SLK-100
• Catalog Number: 04391
• Company DUNS: 147590330
• Company Name: FEMASYS INC.
• Device Count: 5
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859500005165 [Unit of Use]
GS1	20859500005169 [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: 2025-05-12
• Device Publish Date: 2025-05-02

On-Brand Devices [StopLock]

• 30859500005166: StopLock Balloon Inflation Syringe 10-Pack, SLK-100
• 00859500005165: StopLock Balloon Inflation Syringe 5-Pack, SLK-100
• 10859500005162: StopLock Balloon Inflation Syringe 1-Pack , SLK-100