FDA.reportPublic FDA data

Olympus

Primary DI
15019778003603
Brand
Olympus
Company
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
Model
MAJ-1632
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MNKEndoscopic Bite Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNKEndoscopic Bite BlockGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019778003603PrimaryGS10
05019778003606Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1501977800360315019778003603
05019778003606050197780036065019778003606

GMDN Terms#

Term, Definition table
TermDefinition
Intubation teeth protectorA sterile curved device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. Such protection can be required when the patient is resisting the intubation by clenching their teeth which can be damaged against the metal or plastic blade of the intubation laryngoscope, and/or if the patient has bad teeth that are liable to inadvertent damage, and/or if this is normal hospital procedure to counter liability claims. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217061423
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15019778008653OlympusARV110K100376162023-10-30
15019778008660OlympusARV120K100376172023-10-30
15019778008677OlympusARV130K100376182023-10-30
15019778008684OlympusARV140K100376192023-10-30
05019778008656OlympusARV110K100376162023-10-30
05019778008663OlympusARV120K100376172023-10-30
05019778008670OlympusARV130K100376182023-10-30
05019778008687OlympusARV140K100376192023-10-30
15019778000879OlympusEndosonic2016-09-19
15019778007700OlympusMAJ-2207K100350022023-07-18
15019778007717OlympusMAJ-2208K100350032023-07-18
15019778007724OlympusMAJ-2209K100350042023-07-18
15019778007731OlympusMAJ-2210K100350052023-07-18
15019778008516OlympusMAJ-2220K100371612023-07-18
15019778008523OlympusMAJ-2221K100371622023-07-18
15019778008530OlympusMAJ-2222K100371632023-07-18
15019778008547OlympusMAJ-2223K100371642023-07-18
15019778008646OlympusWide-Eye Polyp TrapK100376262023-07-18
15019778005072OlympusMAJ-1681K100266412023-07-05
15019778005089OlympusMAJ-1682K100266862023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970800686855AltonAlton (Shanghai) Medical Instruments Co., Ltd.MNK2025-12-29
06973141950043EndocleanChangzhou Endoclean Medical Device Co.,LtdMNK2025-09-27
04897129991281CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
04897129991304CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
14897129991288CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
04897129991298CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
14897129991301CeroFrictSML Med-Tech Solutions LimitedMNK2025-08-11
00194613120641MSI Precision Specialty InstrumentsMed Saver, Inc.MNK2025-08-01
06936603231128Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
16936603231125Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
00850025860031Breathe-EZMicro-tech UsaMNK2025-03-03
00858276007717Bite Block AdultMicro-tech UsaMNK2025-03-03
00858276007748Breathe-EZMicro-tech UsaMNK2025-03-03
00850025860048Breathe-EZMicro-tech UsaMNK2025-03-03
00858276007724Bite Block AdultMicro-tech UsaMNK2025-03-03
00858276007755Breathe-EZMicro-tech UsaMNK2025-03-03
06926839800595AnreiAnrei Medical(HZ) Co.,Ltd.MNK2025-01-07
10884389151150MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
40884389151151MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
06970057578262Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
16970057578269Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
04897129990758CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
04897129990765CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990755CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990762CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
04897129990727CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
04897129990734CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990724CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
10620974001079Bite BlockSouthmedic IncorporatedMNK2023-06-23