Exploration Ball Probe Set

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Exploration Ball Probe Set FDA UDI
Generic Name: Neurosurgical probe FDA UDI
Device Name: Exploration Ball Probe Set, Consists of the Following: 1 x 7335-40 Exploration Ball Probe 1" Straight, 1 x 7335-42 Exploration Ball Probe 10" 9mm 90 Degree, 1 x 7335-44 Exploration Ball Probe 10" 12mm 90 Degree & 1 x 7335-46 Exploration Ball Probe 10" 15mm 90 Degree FDA UDI
Model / Reference: 7335-00 FDA UDI
Description: Exploration Ball Probe Set, Consists of the Following: 1 x 7335-40 Exploration Ball Probe 1" Straight, 1 x 7335-42 Exploration Ball Probe 10" 9mm 90 Degree, 1 x 7335-44 Exploration Ball Probe 10" 12mm 90 Degree & 1 x 7335-46 Exploration Ball Probe 10" 15mm 90 Degree FDA UDI

Identifiers

Catalog Number: 7335-00 FDA UDI
Primary DI / UDI-DI: 10840199516763 FDA UDI
FDA Product Code: FZS FDA UDI
KAK FDA UDI
GMDN Term: Neurosurgical probe FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: ENT probe, reusable Neurosurgical probe

Exploration Ball Probe Set by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Koros USA, Inc.

Sources (1)

FDA UDI 4348b3cd-db67-4b07-8eb9-5929bcc4fd79 36 fields · synced Jun 8, 2026