SNAP 2.0 Endoscopic Delivery Device

Primary DI
00860012315550
Brand
SNAP 2.0 Endoscopic Delivery Device
Company
G.I. Windows, Inc.
Model
100008
Catalog number
SFM-25A-1
Device description
The SNAP 2.0 Endoscopic Delivery System comes pre-assembled with a Flexagon SFM magnet loaded inside it, with the SFM packed within an Introducer that protects the magnet during transportation and facilitates the introduction of the Flexagon into the endoscope’s working channel. Upon device setup, the SNAP 2.0’s handle section is mounted onto the side of the endoscope with an integrated clip/clamp. The catheter shaft consists of a stainless-steel torque coil that provides column strength to facilitate the Flexagon’s advancement through the gastroscope's 3.7mm minimum working channel for magnet implant placement during gastrointestinal surgery.
Published
2026-01-27
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
K243482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243482000Self-Forming Magnet (Flexagon)GI Windows, Inc.2025-06-11SAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012315550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012315550008600123155508600123155500860012315550

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
077112264
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012315505Titanium Grasper1000212024-08-07
00860012315512FlexFire Universal Handpiece 100016FFU-DLT-12026-01-27
00860012315529FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc 100026FFU-CTG-5A2026-01-27
00860012315536FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc 100027FFU-CTG-5B2026-01-27
00860012315543FlexFire Universal Cartridge OTOLoc Only 100028FFU-CTG-5C2026-01-27

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
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