FDA.report

Anterior Spinal Instrument Tray

Primary DI
00840199544110
Brand
Anterior Spinal Instrument Tray
Company
KOROS U.S.A., INC.
Model
7580-00
Catalog number
7580-00
Device description
Anterior Spinal Instrument Tray Consists of the Following: 1 x 7331-10, 1 x 7331-20, 1 x 7331-22, 1 x 7331-30, 1 x 7331-40, 1 x 7331-50, 1 x 7331-60, 1 x 7331-70-, 1 x 7331-90, 1 x 7386-20, 1 x 7386-30, 1 x 7386-40, 1 x 7386-50, 1 x 7388-20, 1 x 7388-30, 1 x 7388-40, 1 x 7388-50, 1 x 7389-20, 1 x 7389-30, 1 x 7389-40, 1 x 7389-52, 1 x 7349-10, 1 x 7349-20, 1 x 7349-30, 1 x 7349-12, 1 x 7349-22, 1 x 7349-32, 1 x 7462-06, 1 x 7462-09, 1 x 7462-12, 1 x 7462-16 & 1 x 7462-19
Published
2022-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTEElevator

Product Code Classifications

CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840199544110Direct MarkingGS10
10840199544117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199544110008401995441108401995441100840199544110
1084019954411710840199544117

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840199507733Separator7230-157230-152024-12-31
00840199507740Elevator7230-187230-182024-12-31
00840199507757Elevator7230-207230-202024-12-31
00840199507764Elevator7230-257230-252024-12-31
00840199507771Elevator7230-307230-302024-12-31
00840199507788Elevator7230-357230-352024-12-31
00840199507795Elevator7230-407230-402024-12-31
00840199507801Elevator7230-427230-422024-12-31
00840199507818Elevator7230-437230-432024-12-31
00840199507870Elevator7230-607230-602024-12-31
00840199507900Hook7232-057232-052024-12-31
00840199507917Hook7232-107232-102024-12-31
00840199507924Hook7232-157232-152024-12-31
00840199507962Elevator7232-287232-282024-12-31
00840199507979Vein Retractor7232-307232-302024-12-31
00840199507986Vein Retractor7232-357232-352024-12-31
00840199507993Vein Retractor7232-407232-402024-12-31
00840199511426Chisel7315-217315-212024-12-31

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