FDA.reportPublic FDA data

GT Metabolic Magnet - 60mm

Primary DI
00850054216120
Brand
GT Metabolic Magnet - 60mm
Company
Gt Metabolic Solutions, Inc.
Model
MAG-04
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
K261467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261467000GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)Gt Metabolic Solutions, Inc.2026-09-16SAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054216120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054216120008500542161208500542161200850054216120

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.

Regulatory Flags#

DUNS number
108055496
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054216137GT Metabolic Magnet - 70mmMAG-052026-09-30
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
00850054216144GT Metabolic Instrument SetIS-012024-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054216137GT Metabolic Magnet - 70mmGt Metabolic Solutions, Inc.SAH2026-09-30
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
00850054216113GT Metabolic DI Magnet - 50mmGt Metabolic Solutions, Inc.SAH2025-03-14
00850054216052GT Metabolic Delivery SystemGt Metabolic Solutions, Inc.SAH2024-12-13
00850054216069GT Metabolic DI Magnet - 40mmGt Metabolic Solutions, Inc.SAH2024-12-13