BILIARY DRAINAGE TUBE SET
- Primary DI
- 04953170045288
- Brand
- BILIARY DRAINAGE TUBE SET
- Company
- OLYMPUS MEDICAL SYSTEMS CORP.
- Model
- MAJ-256
- Published
- 2016-09-21
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- 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 |
|---|---|
| K933200 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 14953170045285 | Package | GS1 | 1 | In Commercial Distribution |
| 04953170045288 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 14953170045285 | 14953170045285 | |
| 04953170045288 | 04953170045288 | 4953170045288 |
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 |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)401-1086 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 711789789
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
- Sterilization required before use
- true
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 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 15711055100400 | M-Drain | Mermaid Medical A/S | FGE | 2024-10-01 |
| 15711055110041 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055110409 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055120040 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055120453 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055000311 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000328 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000359 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000373 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000410 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000434 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000458 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000472 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000496 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000519 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000533 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000557 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000588 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000595 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000625 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000632 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000663 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000670 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000700 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000724 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000748 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 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 |