Formula 418
- Primary DI
- 10827002429366
- Brand
- Formula 418
- Company
- COOK INCORPORATED
- Model
- G42936
- Catalog number
- FORB4-18-80-7-20
- Device description
- Formula 418 Biliary Stent System
- Published
- 2015-10-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
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 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10827002429366 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10827002429366 | 10827002429366 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bare-metal biliary stent | A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. 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 | Store in dark, dry, cool place. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(812)330-5494 | sharedservices@cookmedical.com |
Regulatory Flags#
- DUNS number
- 042823948
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00827002000766 | Cook | G00076 | MDC-6 | 2020-10-02 |
| 00827002000773 | Cook | G00077 | MDC-7 | 2020-10-02 |
| 00827002000780 | Cook | G00078 | MDC-8 | 2020-10-02 |
| 00827002009653 | Cook | G00965 | MDC-10 | 2020-10-02 |
| 00827002009660 | Cook | G00966 | MDC-5 | 2020-10-02 |
| 00827002010796 | Cook | G01079 | MDC-9 | 2020-10-02 |
| 00827002013209 | Cook | G01320 | MDC-12 | 2020-10-02 |
| 00827002014626 | Cook | G01462 | MDC-14 | 2020-10-02 |
| 00827002016170 | Cook | G01617 | MDC-16 | 2020-10-02 |
| 00827002026896 | Cook | G02689 | MDC-4 | 2020-10-02 |
| 00827002027350 | Cook | G02735 | MDC-3 | 2020-10-02 |
| 00827002048881 | Cook | G04888 | FD-100 | 2020-10-02 |
| 00827002541900 | Guardia | G54190 | J-UOB-4028 | 2016-09-24 |
| 00827002541917 | Guardia | G54191 | J-UOB-4028-ST | 2016-09-24 |
| 00827002614994 | MagniCore | G61499 | MRCHN-20-15.0 | 2026-03-27 |
| 00827002615007 | MagniCore | G61500 | MRCHN-18-10.0 | 2026-03-27 |
| 00827002615014 | MagniCore | G61501 | MRCHN-18-15.0 | 2026-03-27 |
| 00827002615021 | MagniCore | G61502 | MRCHN-18-20.0 | 2026-03-27 |
| 00827002615038 | MagniCore | G61503 | MRCHN-20-10.0 | 2026-03-27 |
| 00827002615045 | MagniCore | G61504 | MRCHN-20-20.0 | 2026-03-27 |
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 |