GEMINI Suture Loop ES4-8000, S4-8000

GUDID 00842071148942

3-0 Braided Polyester Suture Loop with Magnet (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 00842071148942
• NIH Device Record Key: 4f331b96-28d7-42ec-92ec-d620b0610ce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEMINI Suture Loop
• Version Model Number: ES4-8000
• Catalog Number: ES4-8000, S4-8000
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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

Customer Support Contacts

• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071148935 [Primary]
GS1	00842071148942 [Package]; Contains: 00842071148935; Package: Box (S4-8000) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241111

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [GEMINI Suture Loop]

• 00842071147303: GEMINI Suture Loop with Magnet Technology (Pouched)
• 00842071148942: 3-0 Braided Polyester Suture Loop with Magnet (Pouched)