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Radial-Emitting Shaped Fiber Optic Delivery System

FDA UDI

Class II (US FDA UDI)

by Ceram Optec SIA

Identity

Trade Name
Radial-Emitting Shaped Fiber Optic Delivery System FDA UDI
Generic Name
General/multiple surgical laser system beam guide, single-use FDA UDI
Model / Reference
ELVeS® Radial® Slim Fiber 400um, 4F, ID (1x2h) FDA UDI

Identifiers

Catalog Number
101260 FDA UDI
Primary DI / UDI-DI
04049089100252 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

Radial-Emitting Shaped Fiber Optic Delivery System by Ceram Optec SIA — 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
Ceram Optec SIA

Sources (1)

  • FDA UDI 5f627568-98a9-4b64-83e4-13aebcc3dcec 33 fields · synced May 30, 2026