FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearCap Distal Attachment
DI: 08809327350636
·
Model: FM-EC0007
·
FINEMEDIX CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ClearCap Distal Attachment
- Primary DI
- 08809327350636
- Version / Model
- FM-EC0007
- Company Name
- FINEMEDIX CO.,LTD.
- Labeler DUNS
- 688256864
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-11
- Public Version
- 2
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- bf1a4f7e-3dde-45ef-a41b-c25536573992
Device Description
15.7mm/13.3mm
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64014 | Endoscope observation cap, single-use | A short, light-penetrating tube designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap and is available in a range of diameters to accommodate common endoscope diameters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809327350633 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 08809327350636 | GS1 | ||||
| Package | 28809327350630 | GS1 | Box | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +82537418388
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202616 | 000 |