FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Endoscopic Hemoclip
DI: 06970057578118
·
Model: VDK-CD-16-230-P
·
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Endoscopic Hemoclip
- Primary DI
- 06970057578118
- Version / Model
- VDK-CD-16-230-P
- Company Name
- Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
- Labeler DUNS
- 544430136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-20
- Public Version
- 3
- Public Version Date
- 2026-03-27
- Public Version Status
- Update
- Public Device Record Key
- e353254a-f0e4-4d1c-a567-566fa292c302
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61208 | Gastrointestinal endoscopic clip, long-term, non-bioabsorbable | A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970057578115 | GS1 | BOX | 10 | Not in Commercial Distribution | 2026-03-26 |
| Primary | 06970057578118 | GS1 | ||||
| Package | 26970057578112 | GS1 | BOX | 5 | In Commercial Distribution | |
| Package | 56970057578113 | GS1 | carton | 5 | Not in Commercial Distribution | 2026-03-26 |
| Package | 66970057578110 | GS1 | carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222146 | 000 |