FDA UDI
In Commercial Distribution
🇺🇸 United States
X-Tack™
DI: 00191506049157
·
Model: M00505500
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- X-Tack™
- Primary DI
- 00191506049157
- Version / Model
- M00505500
- Catalog Number
- M00505500
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-17
- Public Version
- 1
- Public Version Date
- 2025-02-25
- Public Version Status
- New
- Public Device Record Key
- 78584727-d471-41f5-b7c1-1ebc43e77bcc
Device Description
Endoscopic HeliX Tacking System (Gastric)
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 Conditional
- 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 |
|---|---|---|---|---|
| PKL | Hemostatic metal clip for the GI tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65812 | Gastrointestinal suture anchor | A non-bioabsorbable device designed to be endoscopically implanted into the mucosa/submucosa of the gastrointestinal tract (e.g., stomach, colon) to function as an anchor for a suture used to facilitate healing of post-surgical wounds/defects; the suture may be incorporated into the device. It typically has an invasive corkscrew-like portion and a suture holding/securing aperture or restrainer which protrudes into the bowel lumen. It is made of a metal and typically becomes loose and is egested after the tissue has healed. It is implanted using one or more included dedicated disposable endoscopic implantation/tightening devices. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506049157 | GS1 |