FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tri-Ex
DI: 00827002251663
·
Model: G25166
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tri-Ex
- Primary DI
- 00827002251663
- Version / Model
- G25166
- Catalog Number
- TXR-12-A
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 079720472
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2025-03-03
- Public Version Status
- Update
- Public Device Record Key
- 531f108e-fda8-4296-aa02-4212a3af2027
- Distribution End Date
- 2017-09-11
Device Description
Tri-Ex Extraction Balloon
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| GCA | CATHETER, BILIARY, SURGICAL | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46715 | ERCP catheter, balloon, non-electrical, stone-retrieval | A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002251663 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953951 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.