FDA.reportPublic FDA data

Disposable Bite Block

Primary DI
16970057578269
Brand
Disposable Bite Block
Company
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Model
VDK-KD-B1
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
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
16970057578269PackageGS120In Commercial Distribution
26970057578266PackageGS125In Commercial Distribution
56970057578267PackageGS110In Commercial Distribution
66970057578264PackageGS110In Commercial Distribution
06970057578262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697005757826916970057578269
2697005757826626970057578266
5697005757826756970057578267
6697005757826466970057578264
06970057578262069700575782626970057578262

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
544430136
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
true
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
06941513200089Disposable Non-electric Biopsy ForcepsVDK-FB-30-230-O-P1-B12026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P-A22026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P1-A22026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P-A22026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A22026-05-22
06970057578248Disposable Cleaning BrushVDK-CB-06-230-C2026-05-22
06970057578286Polyp TrapsVDK-PT-052026-05-22
06970057579023Disposable Grasping ForcepsVDK-FG-23-230-A12026-05-22
06970057571027Stone Extraction BalloonVDK-BAL-23-11/13/15-B2026-04-14
06970057577937Disposable SphincterotomeVDK-KE-3025110-A2026-04-14
06970057579061Disposable Grasping ForcepsVDK-FG-23-230-A42026-03-25
06970057573014VedBasket, Stone Extraction BasketsVDK-BAS-23-200-30-S4-A2024-08-20
06970057575032Disposable Polyp SnareVDK-SD-23-230-35-A12024-08-20
06970057578040Disposable Endoscopic HemoclipVDK-CD-13-230-P2024-08-20
06970057578118Disposable Endoscopic HemoclipVDK-CD-16-230-P2024-08-20
06970057573021VedBasket, Stone Extraction BasketsVDK-BAS-23-200-35-S4-A2024-08-20
06970057578002Disposable Endoscopic HemoclipVDK-CD-11-230-P2024-08-20
06970057574486Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
16970057574483Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
06941513210972Disposable Non-electric Biopsy ForcepsVDK-FB-18-70-O-P-B12025-02-26

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
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
10620974001086Bite BlockSouthmedic IncorporatedMNK2023-06-23