Sidecar External Working Channel
- Primary DI
- 00854924006118
- Brand
- Sidecar External Working Channel
- Company
- C2 THERAPEUTICS, INC.
- Model
- FG-1011
- Catalog number
- FG-1011
- Device description
- Sidecar External Working Channel, Endoscopic Accessory
- Published
- 2016-10-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K150083 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00854924006118 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00854924006118 | 00854924006118 | 854924006118 | 0854924006118 |
GMDN Terms#
| Term | Definition |
|---|---|
| Endoscope assembly adaptor | A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 929139249
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00854924006064 | Controller, Full/Swipe | FG-1006 | FG-1006 | 2016-10-19 |
| 00854924006088 | Catheter, Full, Standard | FG-1008 | FG-1008 | 2016-10-19 |
| 00854924006095 | C2 CryoBalloon Focal Catheter, Standard | FG-1009 | FG-1009 | 2016-10-19 |
| 00854924006125 | C2 CryoBalloon Focal Controller | FG-1012 | FG-1012 | 2016-10-19 |
| 00854924006156 | C2 CryoBalloon Swipe Catheter, Standard | FG-1015 | FG-1015 | 2016-10-19 |
| 00854924006248 | C2 CryoBalloon | FG-1024 | FG-1024 | 2018-03-26 |
| 00854924006262 | C2 CryoBalloon | FG-1026 | FG-1026 | 2018-03-26 |
| 00854924006279 | C2 CryoBalloon | FG-1027 | FG-1027 | 2018-03-26 |
| 00854924006286 | C2 CryoBalloon | FG-1028 | FG-1028 | 2018-03-08 |
| 00854924006309 | C2 CryoBalloon | FG-1030 | FG-1030 | 2018-03-08 |
| 00854924006316 | C2 CryoBalloon | FG-1031 | FG-1031 | 2018-03-08 |
| 00854924006323 | C2 CryoBalloon Full 8 Catheter | FG-1032 | FG-1032 | 2016-10-19 |
| 00854924006330 | C2 CryoBalloon Focal Pear Catheter | FG-1033 | FG-1033 | 2016-10-19 |
| 00854924006101 | C2 CryoBalloon Cartridge, Regular | FG-1010 | FG-1010 | 2016-10-19 |
| 00854924006132 | C2 CryoBalloon Cartridge, Large | FG-1013 | FG-1013 | 2016-10-19 |
| 00854924006170 | C2 CryoBalloon | FG-1017 | FG-1017 | 2018-03-08 |
| 00854924006163 | BOA Endoscopic Valve | FG-1016 | FG-1016 | 2016-10-19 |
| 00854924006187 | C2 CryoBalloon | FG-1018 | FG-1018 | 2018-03-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00191506062514 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062521 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062538 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062545 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062552 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062569 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062576 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062583 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 00191506062590 | Navigator™ | BOSTON SCIENTIFIC CORPORATION | FED | 2026-09-25 |
| 06942804744602 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744619 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744626 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744633 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744640 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744657 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744664 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744671 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744688 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744695 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744701 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744718 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744725 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744732 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744749 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744756 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744763 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744770 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744787 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744794 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |
| 06942804744800 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., LTD. | FED | 2026-09-22 |