FDA.reportPublic FDA data

Rhoton Spetzler Type Set

Primary DI
10840199544223
Brand
Rhoton Spetzler Type Set
Company
KOROS U.S.A., INC.
Model
7793-00
Catalog number
7793-00
Device 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
Published
2022-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDIDissector, Surgical, General & Plastic Surgery
LXCMonitor, Pressure, Intracompartmental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
LXCMonitor, Pressure, IntracompartmentalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199544226Direct MarkingGS10
10840199544223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199544226008401995442268401995442260840199544226
1084019954422310840199544223

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10840199531186Impactor7585-447585-442022-03-01
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10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00840183523046BR Surgical, LLCBR Surgical, LLCGDI2024-03-06
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533326DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533357DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533364DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533371DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533449DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533456DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533463DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533470DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533487DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533524DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533531DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533548DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533555DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533562DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533579DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199507853DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507860DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507884DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507891DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507938DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507945DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507952DissectorKOROS U.S.A., INC.GDI2024-02-05