GEM MICROTRAY MAX

Basic Information

• Brand Name: GEM MICROTRAY MAX
• Primary DI: 00844735005875
• Version / Model: GEM2551-2-CS
• Catalog Number: 519321006011
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Labeler DUNS: 031284586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: 6285a36b-fb8b-4f6f-86ec-1d1c059c35cc

Device Description

The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, two MircoClip Appliers and a double tier MicroTray Sterilization Tray.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDO	Applier, surgical, clip	General, Plastic Surgery	878.4800	1
HTD	FORCEPS	General, Plastic Surgery	878.4800	1
KCT	Sterilization wrap containers, trays, cassettes & other accessories	General Hospital	880.6850	2
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61239	Vascular anastomosis coupling kit, reusable	A collection of devices intended to be used to implant a vascular anastomosis coupler [not included] to join vascular (including microvascular) structures by the coupling of two ring-shaped components. It consists of two or more items typically amongst: a coupling approximator for holding the rings of the coupler during approximation, a dedicated forceps/everter for placing the ends of the blood vessel over the pins of the coupler, a vessel diameter guide (sizer), and a sterilization tray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844735005875	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071783	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit