GUDID 00840682113762

GE Medical Systems (Tianjin) Co., Ltd.

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• Primary Device ID: 00840682113762
• NIH Device Record Key: f2f1b2cc-56ce-455b-9f0d-a2dc9aa4d78e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SIGNA Explorer
• Company DUNS: 421356265
• Company Name: GE Medical Systems (Tianjin) 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: false
• 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	00840682113762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143251

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2018-09-19
• Device Publish Date: 2016-08-01

Devices Manufactured by GE Medical Systems (Tianjin) Co., Ltd.

• 00195278707871 - NA: 2024-02-13 SIGNA Champion System Medical Device
• 00195278629234 - NA: 2023-08-14 SIGNA Voyager 1.5T Detachable Table - Wireless Gating
• 00195278616845 - NA: 2023-03-20 SIGNA Victor System Medical Device
• 00195278481382 - NA: 2022-09-16 SIGNA Artist Evo System Medical Device, MDR
• 00840682146302 - NA: 2022-03-15 SIGNA Prime System Medical Device
• 00195278372307 - NA: 2021-06-23 Voyager AIR Medical Device Assembly
• 00195278248923 - NA: 2021-05-04 SIGNA Voyager 1.5T Detachable Table Assembly
• 00195278124609 - NA: 2021-02-10 Kizuna System Medical Device Assembly-MDR