FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08714729751472
·
Model: M0061802010
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 08714729751472
- Version / Model
- M0061802010
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f1415c97-5488-4159-becd-b9dfe2065c50
Device Description
Ureteral Stent Positioner
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
- Yes
- 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 |
|---|---|---|---|---|
| KOA | SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13839 | Urological catheter stylet, transurethral | A sterile, metal wire or flexible rod, typically with a plastic knob at the proximal end, intended to be inserted into the lumen of a urological catheter or cannula (not included) to increase stiffness sufficiently to facilitate manipulation/introduction into the urethra or ureter (via the urethra); it is not intended to assist introduction of a percutaneous catheter. It is available in various lengths, diameters, and degrees of rigidity. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729041245 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08714729751472 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 F Diameter | ||
| Device Size Text, specify | 2.0 mm Diameter | ||
| Device Size Text, specify | 45 cm Length |