CoralWell
- Primary DI
- 16975339628335
- Brand
- CoralWell
- Company
- MacroLux Medical Technology Co., Ltd.
- Model
- NS-1340B
- Published
- 2025-08-26
- 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 |
|---|---|
| K250452 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K250452 | 000 | CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | MacroLux Medical Technology Co., Ltd. | 2025-06-02 | FED |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16975339628335 | Package | GS1 | 1 | In Commercial Distribution |
| 26975339628332 | Package | GS1 | 10 | In Commercial Distribution |
| 06975339628338 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16975339628335 | 16975339628335 | |
| 26975339628332 | 26975339628332 | |
| 06975339628338 | 06975339628338 | 6975339628338 |
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. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 723490133
- 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
- false
- 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 |
|---|---|---|---|---|
| 06975339621506 | BubbleView | C38-CS | 2026-08-14 | |
| 06975339621513 | BubbleView | C38-CRS | 2026-08-14 | |
| 06975339621520 | BubbleView | C50-CB | 2026-08-14 | |
| 06975339621537 | BubbleView | C50-CBR | 2026-08-14 | |
| 06975339621926 | BubbleView | C38-CS | 2026-08-14 | |
| 06975339621933 | BubbleView | C38-CRS | 2026-08-14 | |
| 06975339621964 | BubbleView | C50-CB | 2026-08-14 | |
| 06975339621971 | BubbleView | C50-CBR | 2026-08-14 | |
| 06975339621179 | BubbleView® | C50-C | 2024-07-10 | |
| 06975339621186 | BubbleView® | C50-CR | 2024-07-10 | |
| 06975339621940 | BubbleView® | C50-C | 2025-09-05 | |
| 06975339621957 | BubbleView | C50-CR | 2025-09-05 | |
| 06975339623418 | SeleneView® | HO42 | 2026-07-03 | |
| 06975339628406 | Single-Use Biopsy Forceps | BF-S-1.6×380 | 2026-07-03 | |
| 06975339628413 | Single-Use Alligator Grasper | GF-S-1.6×380 | 2026-07-03 | |
| 06975339628420 | Single-use Endoscopic Scissors | PS-S-1.6×380 | 2026-07-03 | |
| 06975339628512 | Single-Use Biopsy Forceps | BF-F-1.8×600 | 2026-07-03 | |
| 06975339628529 | Single-Use Biopsy Forceps | BF-F-1.8×600-G | 2026-07-03 | |
| 06975339628536 | Single-Use Biopsy Forceps | BF-F-1.8×600-O | 2026-07-03 | |
| 06975339628550 | Single-Use Grasping Forceps | GF-F-1.8×600 | 2026-07-03 |
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 |