Rhoton Spetzler Type Set

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Rhoton Spetzler Type Set FDA UDI
Generic Name: Open-surgery dissector FDA UDI
Device Name: Rhoton Spetzler Type Titanium Set Consists of the Following: 1 x 7793-01, 1 x 7793-02, 1 x 7793-03, 1 x 7793-04, 1 x 7793-05, 1 x 7793-06, 1 x 7793-07, 1 x 7793-08, 1 x 7793-09, 1 x 7793-10, 1 x 7793-11, 1 x 7793-12, 1 x 7793-13, 1 x 7793-15, 1 x 7793-15, 1 x 7793-16, 1 x 7793-17, 1 x 7793-18, 1 x 7793-19, 1 x 7793-20, 1 x 7793-21, 1 x 7793-22 & 1 x 7793-23 FDA UDI
Model / Reference: 7793-00 FDA UDI
Description: Rhoton Spetzler Type Titanium Set Consists of the Following: 1 x 7793-01, 1 x 7793-02, 1 x 7793-03, 1 x 7793-04, 1 x 7793-05, 1 x 7793-06, 1 x 7793-07, 1 x 7793-08, 1 x 7793-09, 1 x 7793-10, 1 x 7793-11, 1 x 7793-12, 1 x 7793-13, 1 x 7793-15, 1 x 7793-15, 1 x 7793-16, 1 x 7793-17, 1 x 7793-18, 1 x 7793-19, 1 x 7793-20, 1 x 7793-21, 1 x 7793-22 & 1 x 7793-23 FDA UDI

Identifiers

Catalog Number: 7793-00 FDA UDI
Primary DI / UDI-DI: 10840199544223 FDA UDI
FDA Product Code: GDI FDA UDI
LXC FDA UDI
GMDN Term: Open-surgery dissector FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Bone file/rasp, manual, reusable Soft-tissue surgical hook, reusable Open-surgery dissector

Rhoton Spetzler Type 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 489c6cf1-b68f-47fd-a2d0-01de82e4c2ef 37 fields · synced May 30, 2026