Disposable Hemostatic Clips
- Primary DI
- 16974529069071
- Brand
- Disposable Hemostatic Clips
- Company
- Ningbo Xinwell Medical Technology Co., Ltd.
- Model
- XY-ZZJ-1B-2.5-2700-135-13
- 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
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 |
|---|---|---|---|---|
| 16974529069071 | Package | GS1 | 10 | In Commercial Distribution |
| 26974529069078 | Package | GS1 | 5 | In Commercial Distribution |
| 06974529069074 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16974529069071 | 16974529069071 | |
| 26974529069078 | 26974529069078 | |
| 06974529069074 | 06974529069074 | 6974529069074 |
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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|---|---|---|---|---|
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| 06971944910172 | Closed Suction Catheters | H112400 | 2025-03-04 | |
| 06971944910189 | Closed Suction Catheters | H114400 | 2025-03-04 | |
| 06971944910196 | Closed Suction Catheters | H116400 | 2025-03-04 | |
| 06971944910202 | Closed Suction Catheters | H118400 | 2025-03-04 | |
| 06971944910219 | Closed Suction Catheters | H110600 | 2025-03-04 | |
| 06971944910226 | Closed Suction Catheters | H112600 | 2025-03-04 | |
| 06971944910233 | Closed Suction Catheters | H114600 | 2025-03-04 | |
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| 06971944910257 | Closed Suction Catheters | H118600 | 2025-03-04 | |
| 06971944910264 | Closed Suction Catheters | H206400 | 2025-03-04 | |
| 06971944910271 | Closed Suction Catheters | H208400 | 2025-03-04 | |
| 06971944910288 | Closed Suction Catheters | H210400 | 2025-03-04 | |
| 06971944910295 | Closed Suction Catheters | H212400 | 2025-03-04 | |
| 06971944910301 | Closed Suction Catheters | H214400 | 2025-03-04 | |
| 06971944910318 | Closed Suction Catheters | H216400 | 2025-03-04 | |
| 06971944910325 | Closed Suction Catheters | H218400 | 2025-03-04 | |
| 06971944910332 | Closed Suction Catheters | H210600 | 2025-03-04 |
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