Identity
- Trade Name
- Rotatable Clip Fixing Device FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip applier FDA UDI
- Model / Reference
- HX-110LR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170200182 FDA UDI
- FDA Product Code
- MND FDA UDI
- GMDN Term
- Gastrointestinal endoscopic clip applier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4400 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Gastrointestinal endoscopic clip applier
Rotatable Clip Fixing Device by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal endoscopic clip applier.
- FJ Clip 5 — CHARMANT INC. · Class I
- FJ Clip Neo 12 — CHARMANT INC. · Class I
- FJ Clip Neo 5 — CHARMANT INC. · Class I
- FJ Clip 12 — CHARMANT INC. · Class I
- Rotatable Clip Fixing Device — Olympus Medical Systems Corporation · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 2cc62903-c8c6-4920-8dd3-cb72f718f647 33 fields · synced May 30, 2026