FDA UDI
In Commercial Distribution
🇺🇸 United States
SNAP 2.0 Endoscopic Delivery Device
DI: 00860012315550
·
Model: 100008
·
G.I. Windows, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SNAP 2.0 Endoscopic Delivery Device
- Primary DI
- 00860012315550
- Version / Model
- 100008
- Catalog Number
- SFM-25A-1
- Company Name
- G.I. Windows, Inc.
- Labeler DUNS
- 077112264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-27
- Public Version
- 1
- Public Version Date
- 2026-02-04
- Public Version Status
- New
- Public Device Record Key
- 2a8a2058-7d91-49af-a1cf-01df7982ca0e
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SAH | Magnetic Compression Anastomosis System | General, Plastic Surgery | 878.4816 | 2 |
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 | 00860012315550 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243482 | 000 |