FDA.report

Henry Schein

Primary DI
00304040028872
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1013277
Catalog number
1013277
Device description
Plaster & Stone Remover
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FLGCleaner, ultrasonic, medical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040028872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040028872003040400288723040400288720304040028872

GMDN Terms

TermDefinition
Medical device disinfectantA substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187487Zirlux920004892000482026-02-04
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00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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Primary DIBrandCompanyProduct codePublished
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00848956021287SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021294SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021317SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00889813067970Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFLG2026-03-22
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07640397422042StatClean Ultrasonic CleanerDent4You AGFLG2026-03-11
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