Philips

GUDID 06970564410390

SENSE FLEX M 3.0T ODU

Shanghai Chenguang Medical Technologies Co., Ltd

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 06970564410390
• NIH Device Record Key: 70c53c1d-5031-4554-858d-53791e2cd168
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips
• Version Model Number: 4522-133-17211
• Company DUNS: 545297822
• Company Name: Shanghai Chenguang Medical Technologies Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970564410390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043147

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2020-03-05
• Device Publish Date: 2016-09-24

On-Brand Devices [Philips]

• 06970564410901: QHC 1H T/R ACS-NT-L
• 06970564410895: SHNC DRIVERBOX 1.5T ODU
• 06970564410888: SYN. BODY COIL 1.5T ODU
• 06970564410871: SYN. BODY COIL 1.5T ODU
• 06970564410864: SYN. BODY COIL 1.5T
• 06970564410840: SHNC DRIVERBOX 1.5T ODU
• 06970564410833: SHNC DRIVERBOX 1.5T
• 06970564410826: SHNC DRIVERBOX 1.0T
• 06970564410819: MICROSCOPY DRIVER 1.5T
• 06970564410802: SYN. BODY COIL 1.5T ODU WITH SLEEVE
• 06970564410796: SYN. BODY COIL 1.5T
• 06970564410772: SYN. BODY COIL 1.5T ODU
• 06970564410758: QUAD HEAD COIL T/R 3T
• 06970564410703: Quad Head Coil 1.5T
• 06970564410673: 3T DS Ped Head-spine 8ch
• 06970564410666: 1.5 T DS Ped Head-spine 8ch
• 06970564410659: 3T DS Ped Torso-cardiac 8ch
• 06970564410642: 1.5T ds Ped Torsocardiac 8ch
• 06970564410598: MICROSCOPY 23MM COIL 1.5T
• 06970564410581: MICROSCOPY 47MM COIL 1.5T
• 06970564410567: Spine 1.5T ODU
• 06970564410550: SENSE SPINE COIL 1.5T
• 06970564410505: SHNC Posterior part 1.5T
• 06970564410499: SHNC Anterior part 1.5T
• 06970564410475: SHNC Posterior part (1.0T)
• 06970564410468: SHNC Anterior part (1.0T)
• 06970564410451: SENSE FLEX-S COIL 3.0T ODU
• 06970564410437: SENSE FLEX S COIL 1.5T ODU
• 06970564410420: SENSE FLEX S COIL 1.5T
• 06970564410390: SENSE FLEX M 3.0T ODU
• 06970564410376: SENSE FLEX M COIL 1.5T ODU
• 06970564410369: SENSE FLEX M COIL 1.5T
• 06970564410338: SENSE FLEX-LARGE COIL 3.0T ODU
• 06970564410314: SENSE FLEX-L COIL 1.5T ODU
• 06970564410307: SENSE FLEX-L COIL 1.5T VEAM
• 06970564410277: SYN. BODY COIL 1.5T-WE1
• 06970564410260: SYN. BODY COIL 1.5T
• 06970564410239: SYN. BODY COIL 1.0T
• 06970564410215: Quad Head Coil 1.5T
• 06970564410192: Pediatric NV Spine coil 3T 8ch
• 06970564410178: Pediatr Body-Cardiac Coil 3T
• 06970564410154: SENSE CARDIAC COIL 1.5T ODU
• 06970564410147: SENSE CARDIAC COIL 1.5T
• 06970564410116: CIRC.COIL C3 1.5T
• 06970564410109: CIRC.COIL C1 1.5T
• 06970564410093: CIRC.COIL C1 1.0T
• 06970564410086: Wrist-Hand coil 1.5T
• 06970564410062: Pediatric NV Spine coil 1.5T 8ch
• 06970564410048: Pediatric Body-Cardiac COIL 1.5T
• 06970564410024: Knee/Foot/Ankle coil