Single Use Biliary Drainage Stent V
- Primary DI
- 14953170346290
- Brand
- Single Use Biliary Drainage Stent V
- Company
- OLYMPUS MEDICAL SYSTEMS CORP.
- Model
- PBD-1030-1208
- Published
- 2016-09-21
- 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
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K103478 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 14953170346290 | Package | GS1 | 1 | In Commercial Distribution |
| 04953170346293 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 14953170346290 | 14953170346290 | |
| 04953170346293 | 04953170346293 | 4953170346293 |
GMDN Terms#
| Term | Definition |
|---|---|
| Biliary drainage catheter | A flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)401-1086 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 711789789
- 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
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04953170158759 | DISPOSABLE HOT BIOPSY FORCEPS | FD-210U | 2016-09-21 | |
| 04953170158766 | DISPOSABLE HOT BIOPSY FORCEPS | FD-230U | 2016-09-21 | |
| 04953170354236 | DISPOSABLE HOT BIOPSY FORCEPS | FD-210U | N5356530 | 2016-09-21 |
| 04953170354243 | DISPOSABLE HOT BIOPSY FORCEPS | FD-230U | N5356630 | 2016-09-21 |
| 04953170214288 | RECORDER UNIT HARNESS | MAJ-1475 | N2483830 | 2023-06-21 |
| 04953170331718 | Light guide | OCS5-LG | 2016-09-21 | |
| 04953170333316 | RECORDER HOLDER | MAJ-2033 | N4472030 | 2016-09-21 |
| 04953170467592 | DISPOSABLE BIOPSY FORCEPS | FB-211D | N5431842 | 2026-04-09 |
| 04953170467608 | DISPOSABLE BIOPSY FORCEPS | FB-221D | N5431942 | 2026-04-09 |
| 04953170467615 | DISPOSABLE BIOPSY FORCEPS | FB-231D | N5432042 | 2026-04-09 |
| 04953170467622 | DISPOSABLE BIOPSY FORCEPS | FB-241D | N5432142 | 2026-04-09 |
| 04953170466038 | Single Use Electrosurgical Hemostatic Forceps | FD-410LR | N1086141 | 2026-04-01 |
| 04953170466182 | Single Use Electrosurgical Hemostatic Forceps | FD-411UR | N3046340 | 2026-04-01 |
| 04953170466267 | Single Use Electrosurgical Hemostatic Forceps | FD-412LR | N5368640 | 2026-04-01 |
| 04953170035647 | ELECTROSURGICAL SNARE | SD-5L-1 | 2016-09-21 | |
| 04953170035708 | ELECTROSURGICAL SNARE | SD-5U-1 | 2016-09-21 | |
| 04953170035838 | ELECTROSURGICAL SNARE | SD-6U-1 | 2016-09-21 | |
| 04953170035951 | ELECTROSURGICAL SNARE | SD-7P-1 | 2016-09-21 | |
| 04953170035968 | ELECTROSURGICAL SNARE | SD-7P-1 | 2016-09-21 | |
| 04953170036033 | ELECTROSURGICAL SNARE | SD-8P-1 | 2016-09-21 |
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| 15711055000670 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000724 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000762 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000779 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000809 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000816 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |