FDA.reportPublic FDA data

GT Metabolic Instrument Set

Primary DI
00850054216144
Brand
GT Metabolic Instrument Set
Company
Gt Metabolic Solutions, Inc.
Model
IS-01
Published
2024-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054216144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054216144008500542161448500542161440850054216144

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal anastomosis coupler, non-bioabsorbableAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
108055496
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054216106GT Metabolic Magnetic Retrieval Device (MRD)MRD-022025-06-20
00850054216113GT Metabolic DI Magnet - 50mmMAG-022025-03-14
00850054216007GT Metabolic Laparoscopic Positioning DevicePD-272024-12-13
00850054216014GT Metabolic Laparoscopic Positioning DevicePD-242024-12-13
00850054216021GT Metabolic Laparoscopic Positioning DevicePD-212024-12-13
00850054216038GT Metabolic Laparoscopic Positioning DevicePD-182024-12-13
00850054216045GT Metabolic Laparoscopic Positioning DevicePD-122024-12-13
00850054216052GT Metabolic Delivery SystemDS-012024-12-13
00850054216069GT Metabolic DI Magnet - 40mmMAG-012024-12-13

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