FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearTip
DI: 08809327356027
·
Model: FM-CTB012N
·
FINEMEDIX CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ClearTip
- Primary DI
- 08809327356027
- Version / Model
- FM-CTB012N
- Catalog Number
- FM-CTB012N
- Company Name
- FINEMEDIX CO.,LTD.
- Labeler DUNS
- 688256864
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- 59c0796d-3aed-41fc-81ee-8edaf9eb8e38
Device Description
EUS-FNB 22G
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
- 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 |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46678 | Flexible endoscopic biopsy handpiece/needle | A sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18809327356024 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 08809327356027 | GS1 |
Customer Contacts
- Phone
- +82537418388
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250994 | 000 |