Disposable Bite Block

GUDID 26970401813586

Zhe Jiang ChuangXiang Medical Technology Co., Ltd.

Suction system bottle/canister sealing set
Primary Device ID26970401813586
NIH Device Record Keya1a2165c-6819-45e5-aa0b-6d79de642d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Bite Block
Version Model NumberMD-BB-AY-01
Company DUNS544434963
Company NameZhe Jiang ChuangXiang Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970401812158 [Primary]
GS116970401813572 [Package]
Contains: 06970401812158
Package: Box [50 Units]
In Commercial Distribution
GS126970401813586 [Package]
Contains: 16970401813572
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

MNKEndoscopic Bite Block

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-03
Device Publish Date2018-12-03

On-Brand Devices [Disposable Bite Block]

26970401813616MD-BB-AY-03
26970401813845MD-BB-CY-01
26970401813586MD-BB-AY-01

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