FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040049990
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004798
Catalog number
9004798
Device description
Iwanson Caliper Spring Blunt
Published
2019-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040049990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040049990003040400499903040400499900304040049990

GMDN Terms#

Term, Definition table
TermDefinition
Interproximal dental gauge, reusableA device intended to be used in dentistry to measure the clearance between adjacent teeth (e.g., in orthodontic treatment during reproximation to relieve pressure points between teeth). The device is typically available in a set of stainless steel graduated gauges, typically with notches on the side to help with identification. Device thickness typically ranges from 0.1 mm to 0.5 mm. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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J003VXSV620451Vortex Size VerifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J0036692981Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
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J0036693021Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693031Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693041Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
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J0036693081Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF11Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVAST1Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX21Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX31Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX41Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX51Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVAST1Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF11Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26