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Saturn 5 Laser System

FDA UDI

Class II (US FDA UDI)

by Research Instruments , Ltd.

Identity

Trade Name
Saturn 5 Laser System FDA UDI
Generic Name
Assisted reproduction laser system FDA UDI
Device Name
Assisted Reproduction Laser FDA UDI
Model / Reference
Saturn 5 Laser System Fixed with RI Viewer Software FDA UDI
Description
Assisted Reproduction Laser FDA UDI

Identifiers

Catalog Number
6-47-501 FDA UDI
Primary DI / UDI-DI
05060170183786 FDA UDI
510(k) Number
K141434 FDA UDI
FDA Product Code
MRX FDA UDI
GMDN Term
Assisted reproduction laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6200 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assisted reproduction laser system

Saturn 5 Laser System by Research Instruments , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction laser system.

Cleared under the same submission

K141434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Research Instruments , Ltd.

Sources (1)

  • FDA UDI 59ab8564-ee61-4e11-8338-c3b1060a3356 36 fields · synced May 31, 2026