FDA.reportPublic FDA data

Sharn Inc

Primary DI
00817518021355
Brand
Sharn Inc
Company
Sharn Anesthesia
Model
35397
Catalog number
35397
Device description
Soft BiteBlock, Medium, Individually Wrapped PK100
Published
2018-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00817518021355PrimaryGS10
00817518021782Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817518021355008175180213558175180213550817518021355
00817518021782008175180217828175180217820817518021782

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-3671mailbox@sharn.com

Regulatory Flags#

DUNS number
107996118
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518020129Sharn IncBAT1-100BAT1-1002018-09-26
00817518022109Sharn IncS2020S20202018-11-16
00817518022123Sharn IncS2020-ES2020-E2018-11-16
00817518022147Sharn IncS2020-MS2020-M2018-11-16
00817518022161Sharn IncS2020-PS2020-P2018-11-16
00817518022550Sharn Anesthesia105604-EU2022-10-27
00817518022567Sharn Anesthesia105605-EU2022-10-27
00817518022574Sharn Anesthesia105606-EU2022-10-27
00817518022581Sharn Anesthesia105607-EU2022-10-27
00817518022598Sharn Anesthesia105608-EU2022-10-27
00817518022468SharnSelect45-18520SS2022-06-20
00817518022475SharnSelect45-18530SS2022-06-20
00817518022482SharnSelect45-18540SS2022-06-20
00817518022499SharnSelect45-18550SS2022-06-20
00817518022505SharnSelect45-18560SS2022-06-20
00817518022512SharnSelect45-18515SS2022-06-20
00817518022529SharnSelect45-18525SS2022-06-20
00817518022536SharnSelect45-185150SS2022-06-20
00817518022543SharnSelect45-185200SS2022-06-20
00817518021546Sharn IncPI-803S-6PI-803S-62018-10-10

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