FDA.reportPublic FDA data

Andorate® Bite Blockwith Strap and Tooth Protector 66Fr

Primary DI
14897106952936
Brand
Andorate® Bite Blockwith Strap and Tooth Protector 66Fr
Company
GA Health Company Limited
Model
SDPC0210F
Published
2020-08-10
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
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
14897106952936PackageGS1100In Commercial Distribution
24897106952933PackageGS1300In Commercial Distribution
04897106952939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489710695293614897106952936
2489710695293324897106952933
04897106952939048971069529394897106952939

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

Regulatory Flags#

DUNS number
686908512
Device count
1
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
false
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
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
14897106957917andorate® 4-piece valve kit1010662026-03-12
14897106958556andorate® 4-piece valve kit1010462026-03-12
14897106958587andorate® 3-piece Valve Kit1010652026-03-12
14897106958617andorate® 4-piece valve kit1010812026-03-12
14897106958624andorate® 4-piece valve kit1010922026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010932026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010942026-03-12
14897106957979andorate® 3-piece Valve Kit1010872026-02-27
14897106958532andorate® 3-piece Valve Kit1010042026-02-27
14897106958549andorate® 3-piece Valve Kit1010372026-02-27
14897106957832Champion 3-piece valve kit1010042026-01-21
14897106957849Champion 3-piece valve kit1010372026-01-21
14897106957856Champion 4-piece valve kit1010462026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit1010472026-01-21

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
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
16936603231125Bite BlockYangzhou Fartley Medical Instrument Technology Co., LtdMNK2025-06-23
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
40884389151151MEDLINEMEDLINE INDUSTRIES, INC.MNK2024-09-20
16970057578269Disposable Bite BlockJiangsu Vedkang Medical Science and Technology Co.,Ltd.MNK2024-08-20
14897129990755CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990762CeroFrictSML Med-Tech Solutions LimitedMNK2023-12-27
14897129990724CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
14897129990731CeroFrictSML Med-Tech Solutions LimitedMNK2023-10-24
00620974001072Bite BlockSouthmedic IncorporatedMNK2023-06-23
00620974001089Bite BlockSouthmedic IncorporatedMNK2023-06-23
00620974001683Bite BlockSouthmedic IncorporatedMNK2023-06-23
04719872108764Bite BlockENTER MEDICAL CORPORATIONMNK2023-06-19
06970401812165Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401812189Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401814077Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816132Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816149Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816156Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816538Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816828Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24
06970401816835Disposable Bite BlockZhejiang Chuangxiang Medical Technology Co., LTD.MNK2023-05-24