I-STOP

GUDID 03760151650338

Sling for female incontinence

CL MEDICAL

Stress urinary incontinence surgical mesh, female

• Primary Device ID: 03760151650338
• NIH Device Record Key: ce063c3f-8d88-43c0-9898-0ac34986d033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-STOP
• Version Model Number: IS-1-A
• Company DUNS: 262825552
• Company Name: CL MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 718-570-2237
• Email: contact@clmedical.com
• Phone: 718-570-2237
• Email: contact@clmedical.com
• Phone: 718-570-2237
• Email: contact@clmedical.com
• Phone: 718-570-2237
• Email: contact@clmedical.com
• Phone: 718-570-2237
• Email: contact@clmedical.com
• Phone: 718-570-2237
• Email: contact@clmedical.com
• Phone: 718-570-2237
• Email: contact@clmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760151650338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051533

FDA Product Code

• OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-05-19

On-Brand Devices [I-STOP]

• 03760151650338: Sling for female incontinence
• 03760151650185: Sling for female incontinence
• 03760151650093: Sling for female incontinence
• 03760151650055: Sling for female incontinence
• 03760151650048: Sling for female incontinence