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Surgimedics®

FDA UDI

Class II (US FDA UDI)

by Coastal Life Technologies, Inc.

Identity

Trade Name
Surgimedics® FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
Fiber Optic Cable, Single-Use Disposable FDA UDI
Model / Reference
9S-6062 FDA UDI
Description
Fiber Optic Cable, Single-Use Disposable FDA UDI

Identifiers

Primary DI / UDI-DI
00814716020456 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

No

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: Urogenital surgical laser system beam guide, single-use

Surgimedics® by Coastal Life Technologies, Inc. — 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
Coastal Life Technologies, Inc.

Sources (1)

  • FDA UDI 156e1055-0eda-4883-ac47-c25bf914546b 33 fields · synced May 30, 2026