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Single use Surgical Optical Fiber

FDA UDI

Class II (US FDA UDI)

by Quanta System Spa

Identity

Trade Name
Single use Surgical Optical Fiber FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
Single use gastro 272 micron Sterile Surgical Optical Fiber FDA UDI
Model / Reference
OAF102791 FDA UDI
Description
Single use gastro 272 micron Sterile Surgical Optical Fiber FDA UDI

Identifiers

Primary DI / UDI-DI
08059173390366 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Urogenital 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

Yes

FDA UDI

Category: Urogenital surgical laser system beam guide, single-use

Single use Surgical Optical Fiber by Quanta System Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urogenital 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
Quanta System Spa

Sources (1)

  • FDA UDI 5ed07505-3ff2-4b82-aef4-4b0fd6ebfcff 33 fields · synced May 30, 2026