FDA UDI
In Commercial Distribution
🇺🇸 United States
RETENTIA Hemoclip
DI: 06936603227916
·
Model: FTL-HC-9-180-O
·
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- RETENTIA Hemoclip
- Primary DI
- 06936603227916
- Version / Model
- FTL-HC-9-180-O
- Catalog Number
- SCA-23-180-09
- Company Name
- Yangzhou Fartley Medical Instrument Technology Co., Ltd
- Labeler DUNS
- 544375774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-18
- Public Version
- 3
- Public Version Date
- 2025-06-11
- Public Version Status
- Update
- Public Device Record Key
- 3f0ed6ec-9b62-4d5f-b702-e4762cbe0e78
Device Description
Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 180cm, 9mm clip length
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 06936603227916 | GS1 | ||||
| Package | 16936603227913 | GS1 | Sales box | 10 | In Commercial Distribution | |
| Package | 26936603227910 | GS1 | Shipping Carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230004 | 000 |