Linear probe

GUDID 06945121407496

CHISON Medical Technologies Co., Ltd.

Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer Rectal ultrasound imaging system transducer
Primary Device ID06945121407496
NIH Device Record Key4b55f4a6-cd6b-4f8a-8c9c-8b50e9e34047
Commercial Distribution StatusIn Commercial Distribution
Brand NameLinear probe
Version Model NumberR7-A
Company DUNS544914187
Company NameCHISON Medical Technologies Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945121407410 [Primary]
GS106945121407496 [Package]
Contains: 06945121407410
Package: [1 Units]
In Commercial Distribution
GS106945121410786 [Package]
Contains: 06945121407410
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-28

On-Brand Devices [Linear probe]

06945121412346D10L30L
06945121412339M8L60L
06945121412322M8L40L
06945121412032L7SVA
06945121411585R7-V
06945121411578L18-V
06945121411561L8M5-V
06945121411554L10i-V
06945121411547L12M-V
06945121411530L12-V
06945121411523L8M-V
06945121411516L12b-V
06945121411509L8Mb-V
06945121411493L7SVA-V
06945121411486L7-V
06945121410342i7L-E
06945121410335L18-E
06945121410243L7-ES
06945121410229L12-D
06945121410144L7R-E
06945121410076L12-E
06945121410069L7W-E
06945121410052L7-E
06945121409049D10L40L
06945121408370L7L
06945121408356R7
06945121408349L7S
06945121408332L7M
06945121407496R7-A
06945121407489L7S-A
06945121407472L7M-A
06945121400213M7L50L
06945121400206D7L40L-REC
06945121400190M10L60L
06945121400183M7L40L
06945121400176D7L30L
06945121400169D12L40L
06945121400152D7L60L
06945121400145D7L40L
06945121413367P2-T
06945121413343L8M6-T
06945121413329E7-T
06945121413312L12-T
06945121413350L7-T
06945121413466L8M-T
069451214145487L

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