FDA.report

Henry Schein

Primary DI
00304040066348
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004670
Catalog number
9004670
Device description
Curette Ear White Disp Large
Published
2019-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JYGCURETTE, EAR

Product Code Classifications

CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040066348PrimaryGS10
10304040066345Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040066348003040400663483040400663480304040066348
1030404006634510304040066345

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012430880
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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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00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
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00304040187647Zirlux920006392000632026-02-04
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Other Devices Sharing Product Codes

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00192896111813Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
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00192896111837Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
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04250381863350Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
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