FDA UDI
In Commercial Distribution
🇺🇸 United States
EsophyX2 HD
DI: 00810275011065
·
Model: R2005
·
ENDOGASTRIC SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EsophyX2 HD
- Primary DI
- 00810275011065
- Version / Model
- R2005
- Company Name
- ENDOGASTRIC SOLUTIONS, INC.
- Labeler DUNS
- 143602659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1464a5cf-54a3-4304-9c42-be55477b61ac
Device Description
EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
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
- 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 |
|---|---|---|---|---|
| 37390 | Endoscopic suturing unit, single-use | A sterile, manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810275011065 | GS1 |
Customer Contacts
- Phone
- 425-307-9269
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142113 | 000 |