S.M.A.R.T.
- Primary DI
- 20705032024959
- Brand
- S.M.A.R.T.
- Company
- Cordis US Corp.
- Model
- C14040MB
- Catalog number
- C14040MB
- Device description
- SMART 7FR 120CM BILIARY 14X40
- Published
- 2017-09-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Product 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 |
|---|---|
| K031777 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20705032024959 | Primary | GS1 | 0 | |
| 10705032024952 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20705032024959 | 20705032024959 |
| 10705032024952 | 10705032024952 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bare-metal biliary stent | A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 118274128
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10705032100656 | VISTA BRITE TIP | 778-052-00M | 778-052-00M | 2024-09-09 |
| 10705032100663 | VISTA BRITE TIP | 778-082-00M | 778-082-00M | 2024-09-09 |
| 10705032100748 | VISTA BRITE TIP | 670-190-00M | 670-190-00M | 2024-09-09 |
| 10705032100830 | VISTA BRITE TIP | 670-040-00M | 670-040-00M | 2024-09-09 |
| 10705032100892 | VISTA BRITE TIP | 778-034-00M | 778-034-00M | 2024-09-09 |
| 10705032100922 | VISTA BRITE TIP | 670-008-00M | 670-008-00M | 2024-09-09 |
| 10705032100953 | VISTA BRITE TIP | 778-270-00M | 778-270-00M | 2024-09-09 |
| 10862028000434 | MYNX CONTROL | MX6760 | MX6760 | 2018-10-22 |
| 10862028000427 | MYNX CONTROL | MX5060 | MX5060 | 2018-10-22 |
| 20705032036440 | Cordis PRECISE PRO Rx Nitinol Stent System | PC0720RXC | PC0720RXC | 2014-09-17 |
| 10705032009768 | AVANTI | 504405X | 504405X | 2016-08-01 |
| 10705032009775 | AVANTI | 504406X | 504406X | 2016-08-01 |
| 10705032009799 | AVANTI | 504408X | 504408X | 2016-08-01 |
| 10705032009881 | AVANTI | 504509X | 504509X | 2016-08-01 |
| 10705032009898 | AVANTI | 504604A | 504604A | 2016-08-01 |
| 10705032009904 | AVANTI | 504604P | 504604P | 2016-08-01 |
| 10705032009911 | AVANTI | 504604S | 504604S | 2016-08-01 |
| 10705032009935 | AVANTI | 504604X | 504604X | 2016-08-01 |
| 10705032009942 | AVANTI | 504605A | 504605A | 2016-08-01 |
| 10705032009959 | AVANTI | 504605P | 504605P | 2016-08-01 |
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 |