FDA.reportPublic FDA data

GT Metabolic DI Magnet - 50mm

Primary DI
00850054216113
Brand
GT Metabolic DI Magnet - 50mm
Company
Gt Metabolic Solutions, Inc.
Model
MAG-02
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SAHMagnetic Compression Anastomosis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAHMagnetic Compression Anastomosis SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243359000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243359000MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc.2025-02-28SAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054216113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054216113008500542161138500542161130850054216113

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

Regulatory Flags#

DUNS number
108055496
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054216106GT Metabolic Magnetic Retrieval Device (MRD)MRD-022025-06-20
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
00850054216144GT Metabolic Instrument SetIS-012024-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012315512FlexFire Universal Handpiece G.I. Windows, Inc.SAH2026-01-27
00860012315529FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc G.I. Windows, Inc.SAH2026-01-27
00860012315536FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc G.I. Windows, Inc.SAH2026-01-27
00860012315543FlexFire Universal Cartridge OTOLoc Only G.I. Windows, Inc.SAH2026-01-27
00860012315550SNAP 2.0 Endoscopic Delivery DeviceG.I. Windows, Inc.SAH2026-01-27
00850054216052GT Metabolic Delivery SystemGt Metabolic Solutions, Inc.SAH2024-12-13
00850054216069GT Metabolic DI Magnet - 40mmGt Metabolic Solutions, Inc.SAH2024-12-13