FDA.reportPublic FDA data

Cervical SL5 Micro Curette Set

Primary DI
10840199543776
Brand
Cervical SL5 Micro Curette Set
Company
KOROS U.S.A., INC.
Model
7420-00
Catalog number
7420-00
Device description
Cervical SL5 Micro Curette Set Consists of the Following:1 x 7420-80, 4 x 7420-60, 1 x 7420-50, 1 x 7420-40, 1 x 7420-30, 1 x 7420-20, 1 x 7420-10, 1 x 7422-60, 1 x 7422-50, 1 x 7422-40, 1 x 7422-30, 1 x 7424-20, 1 x 7424-10 & 1 x 7420-90
Published
2022-10-31
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
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199543779Direct MarkingGS10
10840199543776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199543779008401995437798401995437790840199543779
1084019954377610840199543776

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use 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

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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

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