FDA UDI
In Commercial Distribution
🇺🇸 United States
SerosaFuse®
DI: 00884450848128
·
Model: A
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SerosaFuse®
- Primary DI
- 00884450848128
- Version / Model
- A
- Catalog Number
- R2175
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-14
- Public Version
- 1
- Public Version Date
- 2026-01-22
- Public Version Status
- New
- Public Device Record Key
- 19cd9943-d0d0-43ce-a0fc-0d185245d49e
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ODE | Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66680 | Gastro-oesophageal antireflux intraluminal fundoplication clip | An implantable device designed to be transorally inserted during an endoscopic procedure to secure the stomach fundus to the oesophagus above the gastro-oesophageal junction to create a partial intraluminal fundoplication for the prevention of gastro-oesophageal reflux. It is made of non-bioabsorbable synthetic polymer materials and is typically supplied in a cartridge containing multiple clips/fasteners; a dedicated endoscopic implantation tool may be included with the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884450848128 | GS1 |