FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearEndoclip
DI: 08809327353095
·
Model: FM-CLD11-090(2300)
·
FINEMEDIX CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ClearEndoclip
- Primary DI
- 08809327353095
- Version / Model
- FM-CLD11-090(2300)
- Company Name
- FINEMEDIX CO.,LTD.
- Labeler DUNS
- 688256864
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-19
- Public Version
- 1
- Public Version Date
- 2020-10-27
- Public Version Status
- New
- Public Device Record Key
- 06c1a20b-14ac-4995-a83f-53c1d223ac84
Device Description
11mm/90°/2300mm
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 61207 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809327353092 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 08809327353095 | GS1 |
Customer Contacts
- Phone
- +82537418388
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200217 | 000 |