Linear probe

GUDID 06945121400190

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06945121400190
• NIH Device Record Key: 8d1030d1-9b02-4b53-9e4c-b6cf387102ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Linear probe
• Version Model Number: M10L60L
• Company DUNS: 544914187
• Company Name: CHISON Medical Technologies Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945121400190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153085

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

On-Brand Devices [Linear probe]

• 06945121412346: D10L30L
• 06945121412339: M8L60L
• 06945121412322: M8L40L
• 06945121412032: L7SVA
• 06945121411585: R7-V
• 06945121411578: L18-V
• 06945121411561: L8M5-V
• 06945121411554: L10i-V
• 06945121411547: L12M-V
• 06945121411530: L12-V
• 06945121411523: L8M-V
• 06945121411516: L12b-V
• 06945121411509: L8Mb-V
• 06945121411493: L7SVA-V
• 06945121411486: L7-V
• 06945121410342: i7L-E
• 06945121410335: L18-E
• 06945121410243: L7-ES
• 06945121410229: L12-D
• 06945121410144: L7R-E
• 06945121410076: L12-E
• 06945121410069: L7W-E
• 06945121410052: L7-E
• 06945121409049: D10L40L
• 06945121408370: L7L
• 06945121408356: R7
• 06945121408349: L7S
• 06945121408332: L7M
• 06945121407496: R7-A
• 06945121407489: L7S-A
• 06945121407472: L7M-A
• 06945121400213: M7L50L
• 06945121400206: D7L40L-REC
• 06945121400190: M10L60L
• 06945121400183: M7L40L
• 06945121400176: D7L30L
• 06945121400169: D12L40L
• 06945121400152: D7L60L
• 06945121400145: D7L40L
• 06945121413367: P2-T
• 06945121413343: L8M6-T
• 06945121413329: E7-T
• 06945121413312: L12-T
• 06945121413350: L7-T
• 06945121413466: L8M-T
• 06945121414548: 7L
• 06945121415385: L8M5-T