Single Use Ureteral Access Sheath
- Primary DI
- 06942804745623
- Brand
- Single Use Ureteral Access Sheath
- Company
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- Model
- MD-B-AS-1152
- Published
- 2026-09-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- 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 |
|---|---|
| K260410 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06942804745623 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06942804745623 | 06942804745623 | 6942804745623 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ureteral introduction sheath | A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 544434963
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06936534328911 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL181024 | 2026-09-29 | |
| 06936534328928 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL181018 | 2026-09-29 | |
| 06936534328935 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL181524 | 2026-09-29 | |
| 06936534328942 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL181518 | 2026-09-29 | |
| 06936534328959 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL182524 | 2026-09-29 | |
| 06936534328966 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL182518 | 2026-09-29 | |
| 06936534328973 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL241024 | 2026-09-29 | |
| 06936534328980 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL241018 | 2026-09-29 | |
| 06936534328997 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL241524 | 2026-09-29 | |
| 06936534329000 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL241518 | 2026-09-29 | |
| 06936534329017 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL242524 | 2026-09-29 | |
| 06936534329024 | Polypectomy Snare (NON-ELECTRICAL) | MD-E-FL242518 | 2026-09-29 | |
| 06936534329031 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL181024 | 2026-09-29 | |
| 06936534329048 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL181018 | 2026-09-29 | |
| 06936534329055 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL181524 | 2026-09-29 | |
| 06936534329062 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL181518 | 2026-09-29 | |
| 06936534329079 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL182524 | 2026-09-29 | |
| 06936534329086 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL182518 | 2026-09-29 | |
| 06936534329093 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL241024 | 2026-09-29 | |
| 06936534329109 | Polypectomy Snare (NON-ELECTRICAL) | MD-H-FL241018 | 2026-09-29 |
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 |