GT Metabolic Instrument Set

Basic Information

• Brand Name: GT Metabolic Instrument Set
• Primary DI: 00850054216144
• Version / Model: IS-01
• Company Name: Gt Metabolic Solutions, Inc.
• Labeler DUNS: 108055496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-13
• Public Version: 1
• Public Version Date: 2024-12-23
• Public Version Status: New
• Public Device Record Key: 82b125b6-ed61-4449-9613-c7daef6414d1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18135	Gastrointestinal anastomosis coupler, non-bioabsorbable	An implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. This device is made of a substance or material that cannot be chemically degraded or absorbed via natural body processes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850054216144	GS1