FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040016268
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1046638
Catalog number
1046638
Device description
Mirror Laryngeal W/O Handle
Published
2019-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KAIMIRROR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040016268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040016268003040400162683040400162680304040016268

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417642MillenniumAvalign Technologies, Inc.KAI2026-03-04
00190776415709MillenniumAvalign Technologies, Inc.KAI2026-02-04
09348811109620INKAThe Trustee for KAISER FAMILY TRUSTKAI2025-11-25
04250676710079Atticus mirrorSpiggle & Theis Medizintechnik GmbHKAI2025-09-25
04250676718006Mirror, round, polishedSpiggle & Theis Medizintechnik GmbHKAI2025-09-19
00194613011741MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011758MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011772MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011789MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
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00194613049515MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613103385MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
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