FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydratome™ Pro RX 44
DI: 00191506039271
·
Model: M00584430
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hydratome™ Pro RX 44
- Primary DI
- 00191506039271
- Version / Model
- M00584430
- Catalog Number
- M00584430
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-25
- Public Version
- 1
- Public Version Date
- 2023-11-02
- Public Version Status
- New
- Public Device Record Key
- 900fb5b2-4056-492a-a5d2-6ad58ae4ef47
Device Description
Sphincterotome
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
- 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
- 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 |
|---|---|---|---|---|
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65185 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506039271 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.035in GW diameter | ||
| Device Size Text, specify | 0.89mm GW diameter | ||
| Device Size Text, specify | 450cm GW length |