Disposable Hemostatic Clips
- Primary DI
- 16974529068487
- Brand
- Disposable Hemostatic Clips
- Company
- Ningbo Xinwell Medical Technology Co., Ltd.
- Model
- XY-ZZJ-1B-2.5-1650-135-13
- Device description
- Disposable Hemostatic Clips
- Published
- 2024-11-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K232969 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16974529068487 | Package | GS1 | 10 | In Commercial Distribution |
| 26974529068484 | Package | GS1 | 5 | In Commercial Distribution |
| 06974529068480 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Gastrointestinal endoscopic clip, short-term | A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 544587864
- 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
- true
- Sterilization required before use
- false
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|---|---|---|---|---|
| 26971944910145 | Closed Suction Catheters | H106400 | 2025-03-04 | |
| 26971944910152 | Closed Suction Catheters | H108400 | 2025-03-04 | |
| 26971944910169 | Closed Suction Catheters | H110400 | 2025-03-04 | |
| 26971944910176 | Closed Suction Catheters | H112400 | 2025-03-04 | |
| 26971944910183 | Closed Suction Catheters | H114400 | 2025-03-04 | |
| 26971944910190 | Closed Suction Catheters | H116400 | 2025-03-04 | |
| 26971944910206 | Closed Suction Catheters | H118400 | 2025-03-04 | |
| 26971944910213 | Closed Suction Catheters | H110600 | 2025-03-04 | |
| 26971944910220 | Closed Suction Catheters | H112600 | 2025-03-04 | |
| 26971944910237 | Closed Suction Catheters | H114600 | 2025-03-04 | |
| 26971944910244 | Closed Suction Catheters | H116600 | 2025-03-04 | |
| 26971944910251 | Closed Suction Catheters | H118600 | 2025-03-04 | |
| 26971944910268 | Closed Suction Catheters | H206400 | 2025-03-04 | |
| 26971944910275 | Closed Suction Catheters | H208400 | 2025-03-04 | |
| 26971944910282 | Closed Suction Catheters | H210400 | 2025-03-04 | |
| 26971944910299 | Closed Suction Catheters | H212400 | 2025-03-04 | |
| 26971944910305 | Closed Suction Catheters | H214400 | 2025-03-04 | |
| 26971944910312 | Closed Suction Catheters | H216400 | 2025-03-04 | |
| 26971944910329 | Closed Suction Catheters | H218400 | 2025-03-04 | |
| 26971944910336 | Closed Suction Catheters | H210600 | 2025-03-04 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 16959664914516 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-03-24 |
| 16936603227715 | Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd | PKL | 2026-01-26 |
| 06975543351923 | Alton | Alton (Shanghai) Medical Instruments Co., Ltd. | PKL | 2026-01-26 |
| 06975543351947 | Alton | Alton (Shanghai) Medical Instruments Co., Ltd. | PKL | 2026-01-26 |
| 06975543352005 | Alton | Alton (Shanghai) Medical Instruments Co., Ltd. | PKL | 2026-01-26 |
| 06975543352029 | Alton | Alton (Shanghai) Medical Instruments Co., Ltd. | PKL | 2026-01-26 |
| 16959664903145 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664903152 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664903930 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664903947 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664903961 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914219 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914226 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914233 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914240 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914257 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914264 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914295 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914301 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914318 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914332 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914349 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914356 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914370 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914387 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914394 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914417 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914424 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914431 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |
| 16959664914455 | NA | Hangzhou AGS MedTech Co., Ltd. | PKL | 2026-01-25 |