FDA.report

Comfort Plus Osteotome Set

Primary DI
00840199544004
Brand
Comfort Plus Osteotome Set
Company
KOROS U.S.A., INC.
Model
7533-00
Catalog number
7533-00
Device description
Comfort Plus Osteotome Curved 20cm Handles Set Consists of the Following: 1 x 7533-06, 1 x 7533-10, 1 x 7533-15, 1 x 7533-20, 1 x 7533-25 & 1 x 7533-30
Published
2024-02-01
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
KDGChisel (Osteotome)

Product Code Classifications

CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840199544004Direct MarkingGS10
10840199544001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199544004008401995440048401995440040840199544004
1084019954400110840199544001

GMDN Terms

TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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

Other Devices From This Company

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00840199528837Comfort Plus Chisel7540-067540-062025-01-31
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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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00810158218635PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
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