Ultratome XL
- Primary DI
- 08714729103257
- Brand
- Ultratome XL
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M00535900
- Device description
- Triple Lumen Sphincterotome
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| FDI | SNARE, FLEXIBLE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FDI | Snare, Flexible | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729103257 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729103257 | 08714729103257 | 8714729103257 |
GMDN Terms
| Term | Definition |
|---|---|
| ERCP catheter, non-balloon, electrosurgical | A flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
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| 08714729879947 | EP XT™ | M0046EPXT00390 | M0046EPXT00390 | 2016-09-24 |
| 08714729181088 | Percuflex™ Biliary | M00533760 | 2015-09-24 | |
| 08714729181095 | Percuflex™ Biliary | M00533770 | 2015-09-24 | |
| 08714729181101 | Percuflex™ Biliary | M00533780 | 2015-09-24 | |
| 08714729181118 | Percuflex™ Biliary | M00533790 | 2015-09-24 | |
| 08714729181125 | Percuflex™ Biliary | M00533800 | 2015-09-24 | |
| 08714729181132 | Percuflex™ Biliary | M00533810 | 2015-09-24 | |
| 08714729181149 | Percuflex™ Biliary | M00533820 | 2015-09-24 | |
| 08714729181156 | Percuflex™ Biliary | M00533830 | 2015-09-24 | |
| 08714729181163 | Percuflex™ Biliary | M00533850 | 2015-09-24 | |
| 08714729181217 | Percuflex™ Biliary | M00533610 | 2015-09-24 | |
| 08714729181224 | Percuflex™ Biliary | M00533620 | 2015-09-24 | |
| 08714729181231 | Percuflex™ Biliary | M00533630 | 2015-09-24 | |
| 08714729181248 | Percuflex™ Biliary | M00533640 | 2015-09-24 | |
| 08714729181255 | Percuflex™ Biliary | M00533650 | 2015-09-24 |
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