Single Use Hemoclip
- Primary DI
- 26970401813296
- Brand
- Single Use Hemoclip
- Company
- Zhe Jiang ChuangXiang Medical Technology Co., Ltd.
- Model
- MD-G-HR-195-12-135-Y
- Published
- 2018-09-25
- 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#
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 16970401813282 | Package | GS1 | 10 | In Commercial Distribution |
| 26970401813296 | Package | GS1 | 5 | In Commercial Distribution |
| 06970401811229 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 16970401813282 | 16970401813282 | |
| 26970401813296 | 26970401813296 | |
| 06970401811229 | 06970401811229 | 6970401811229 |
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
- 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
- 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 |
|---|---|---|---|---|
| 16970401815095 | Disposable Valve Sets | MD-B-AW01 | 2020-04-23 | |
| 26970401814286 | Non-Rotatable Snares | MD-E-SNC241524 | 2019-10-23 | |
| 26970401814262 | Non-Rotatable Snares | MD-E-SNC243224 | 2019-10-23 | |
| 26970401814309 | Rotatable Snares | MD-E-SNR241524 | 2019-10-23 | |
| 26970401813739 | Cleaning Brush | MD-A-BR-2306 | 2019-01-09 | |
| 26970401813456 | Cleaning Brush | MD-B-BR-2306 | 2018-11-23 | |
| 26970401813470 | Cleaning Brush | MD-B-BR-0510 | 2018-11-23 | |
| 26970401813647 | Cleaning Brush | MD-D-BR-0510 | 2018-12-10 | |
| 26970401814248 | Single Use Biopsy Forceps | MD-B-BF2418 | 2019-09-25 | |
| 26970401813975 | Single Use Biopsy Forceps | MD-C-BF2403 | 2019-06-04 | |
| 26970401814002 | Single Use Grasping Forceps | MD-C-GF2403 | 2019-06-04 | |
| 26970401813944 | Single Use Biopsy Forceps | MD-A-BF2418 | 2019-04-29 | |
| 26970401812862 | Single Use Hemoclip | MD-L-HR-270-15-135-Y | 2019-03-22 | |
| 26970401813913 | Single Use Guidewire | MD-S-GW3545 | 2019-03-23 | |
| 26970401813890 | Single Use Hemoclip | MD-C-HR-270-13-135-Y | 2019-03-22 | |
| 26970401813401 | Single Use Biopsy Forceps | MD-A-BF2416 | 2019-02-26 | |
| 26970401813845 | Disposable Bite Block | MD-BB-CY-01 | 2019-02-26 | |
| 26970401813210 | Rotatable Snares | MD-E-SNR243224 | 2018-09-25 | |
| 26970401813715 | Single Use Hemoclip | MD-G-HR-230-12-135-N | 2019-01-08 | |
| 16970401813671 | Single Use Biopsy Forceps | MD-B-BF2423 | 2019-01-04 |
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