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Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber

FDA UDI

Class II (US FDA UDI)

by Trimedyne, Inc.

Identity

Trade Name
Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber FDA UDI
Generic Name
General/multiple surgical laser system beam guide, single-use FDA UDI
Device Name
Fiber, Bare, 365um, Single Use, TMED Connector FDA UDI
Model / Reference
S365 FDA UDI
Description
Fiber, Bare, 365um, Single Use, TMED Connector FDA UDI

Identifiers

Catalog Number
S365 FDA UDI
Primary DI / UDI-DI
M473S3650 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical laser system beam guide, single-use 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber by Trimedyne, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical laser system beam guide, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trimedyne, Inc.

Sources (1)

  • FDA UDI bd19b31b-f9ba-44b6-97d3-68f6d93d7f28 35 fields · synced Jun 8, 2026