GEMINI ESD221C-07, SD221C-07-101, SD221C-07-105

GUDID 00842071145002

GEMINI Suture Passer with Magnet Technology (Curved Needle, Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Suturing unit, single-use

• Primary Device ID: 00842071145002
• NIH Device Record Key: 281b27f9-13a5-4b34-a54d-e6c626a5a6e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEMINI
• Version Model Number: ESD221C-07
• Catalog Number: ESD221C-07, SD221C-07-101, SD221C-07-105
• 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: true
• 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
• 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	00842071144999 [Primary]
GS1	00842071145002 [Package]; Contains: 00842071144999; Package: Box (SD221C-07-101) [1 Units]; In Commercial Distribution
GS1	00842071145019 [Package]; Contains: 00842071144999; Package: Box (SD221C-07-105) [5 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: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [GEMINI]

• 00842071145002: GEMINI Suture Passer with Magnet Technology (Curved Needle, Pouched)
• 00842071144975: GEMINI Suture Passer with Magnet Technology (Straight Needle, Pouched)