Identity
- Trade Name
- HM-365A FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue extension sleeves with logo, EO sterile, Flat Tip, IML label FDA UDI
- Model / Reference
- HM-365A FDA UDI
- Description
- Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue extension sleeves with logo, EO sterile, Flat Tip, IML label FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851272007071 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
Hm-365a by International Medical Lasers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, reusable.
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- ProFlex — INNOVAQUARTZ LLC · Class II
- Q-Lase™ Side-Firing Laser Fiber with SMA Connector — OPTICAL INTEGRITY, INC. · Class II
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- Twister — WISDOM MEDICAL TECHNOLOGY, LLC · 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
- International Medical Lasers, Inc.
Sources (1)
- FDA UDI d8cf85df-478c-4c3d-ab1d-1572947ad56b 34 fields · synced May 30, 2026