FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040006368
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1010285
Catalog number
1010285
Device description
Maxispray Plus
Published
2020-03-09
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
false

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040006365PrimaryGS10
00304040006368Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404000636510304040006365
00304040006368003040400063683040400063680304040006368

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
012430880
Device count
4
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344029317MEDLINEMEDLINE INDUSTRIES, INC.LRJ2026-04-27
04039239075462Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
04039239075479Citric Acid 50%B. BRAUN MEDICAL INC.LRJ2026-04-03
00884392008420Safety 1stDOREL JUVENILE GROUP, INC.LRJ2025-12-15
10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
08859335502220POSE HEALTH CARE LIMITED POSE HEALTH CARE LIMITEDLRJ2025-09-05
00615375013458CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00615375013472CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013455CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
00025469093455Ecolab Bleach Disinfectant WipeEcolab Inc.LRJ2025-05-09
00850065253244LIVE TULA Alcohol Pads 1.0 (100pcs/box)TULA HEALTH, INC.LRJ2025-03-18
06976301910710YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910727YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910734YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910741YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910758YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910765YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910772YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910789YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
06976301910796YingtaiChangsha Yingtai Instrument Co., LtdLRJ2025-03-01
10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
10197344017690MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28