GEMINI

Basic Information

• Brand Name: GEMINI
• Primary DI: 00842071148973
• Version / Model: ESD221-S-07
• Catalog Number: ESD221-S-07, SD221-S-07-101, SD221-S-07-105
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-07
• Public Version: 1
• Public Version Date: 2025-03-17
• Public Version Status: New
• Public Device Record Key: f804c4e3-a761-48e1-8719-5a0a3d7d06b7

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842071148980	GS1	Box (SD221-S-07-101)	1	In Commercial Distribution
Primary	00842071148973	GS1
Package	00842071148997	GS1	Box (SD221-S-07-105)	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241111	000