Identity
- Trade Name
- FJ Clip 12 FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip applier FDA UDI
- Model / Reference
- 24-0002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883475951677 FDA UDI
- FDA Product Code
- GDO FDA UDI
- GMDN Term
- Gastrointestinal endoscopic clip applier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Gastrointestinal endoscopic clip applier
FJ Clip 12 by Charmant Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip applier.
- Rotatable Clip Fixing Device — Olympus Medical Systems Corporation · Class II
- Rotatable Clip Fixing Device — Olympus Medical Systems Corporation · Class II
- FJ Clip 5 — CHARMANT INC. · Class I
- FJ Clip Neo 12 — CHARMANT INC. · Class I
- FJ Clip Neo 5 — CHARMANT INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Charmant Inc.
Sources (1)
- FDA UDI 23bd93e6-02e0-4772-835a-6538a7a17fb6 32 fields · synced May 30, 2026