"PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018"" Delivery System"
- Primary DI
- 20705032037164
- Brand
- "PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018"" Delivery System"
- Company
- CORDIS CORPORATION
- Model
- PG1280BSS
- Catalog number
- PG1280BSS
- Published
- 2015-08-28
- 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 |
|---|---|
| K021345 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20705032037164 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20705032037164 | 20705032037164 |
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 |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not use open or damaged packages |
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dark, dry place. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 806136177
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10705032000512 | AVANTI+ | 402604T | 402604T | 2016-08-01 |
| 10705032000550 | AVANTI | 402605R | 402605R | 2016-08-01 |
| 10705032000772 | AVANTI+ | 402611T | 402611T | 2016-08-01 |
| 10705032009751 | AVANTI | 504404X | 504404X | 2016-08-01 |
| 10705032009782 | AVANTI | 504407X | 504407X | 2016-08-01 |
| 10705032009805 | AVANTI | 504409X | 504409X | 2016-08-01 |
| 10705032009812 | AVANTI | 504504S | 504504S | 2016-08-01 |
| 10705032009829 | AVANTI | 504505S | 504505S | 2016-08-01 |
| 10705032009836 | AVANTI | 504505X | 504505X | 2016-08-01 |
| 10705032009843 | AVANTI | 504506S | 504506S | 2016-08-01 |
| 10705032009850 | AVANTI | 504506X | 504506X | 2016-08-01 |
| 10705032009867 | AVANTI | 504507X | 504507X | 2016-08-01 |
| 10705032009874 | AVANTI | 504508X | 504508X | 2016-08-01 |
| 10705032009928 | AVANTI | 504604T | 504604T | 2016-08-01 |
| 10705032009973 | AVANTI | 504605T | 504605T | 2016-08-01 |
| 10705032010009 | AVANTI | 504606D | 504606D | 2016-08-01 |
| 10705032010016 | AVANTI | 504606P | 504606P | 2016-08-01 |
| 10705032010023 | AVANTI | 504606S | 504606S | 2016-08-01 |
| 10705032010030 | AVANTI | 504606T | 504606T | 2016-08-01 |
| 10705032010054 | AVANTI | 504606X | 504606X | 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 |