Philips

GUDID 00884838118270

dS Breast Coil 7ch 1.5T

Philips Medical Systems Nederland B.V.

MRI system coil, radio-frequency

• Primary Device ID: 00884838118270
• NIH Device Record Key: b11c30d1-ba8c-4d1f-8ece-792aa3348ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips
• Version Model Number: 459801728813
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 110 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838118270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232762

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-02
• Device Publish Date: 2024-04-24

On-Brand Devices [Philips]

• 00884838118270: dS Breast Coil 7ch 1.5T
• 00884838120242: Biopsy Grid, Sterilized
• 00884838120211: Breast Grid (User-Sterilized)
• 00884838118782: BREAST 7 BIOPSY PACK, 1.5T contains - 3 Grid Immobilization Plate LBS M-L; 3 Pillar Immobilizati
• 00884838118775: Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Grid Block Assembly; 3 Grid
• 00884838118768: dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grid, Upper dS Breast 16Ch I/T; 4 Medial Gri
• 00884838118751: Lateral Grid, Lower dS Breast 16CH I/T
• 00884838118744: Lateral Grid, Upper dS Breast 16CH I/T
• 00884838118737: Medial Grid dS Breast 16CH I/T
• 00884838118720: Lateral Grid dS Breast 16CH I/T
• 00884838118713: Grid Plate, Enhanced Access Medial
• 00884838118706: Grid Plate Enhanced Access, Lateral
• 00884838118683: Pillar Immobilization Plate
• 00884838118676: Pillar Immobilization Plate LBS M-L
• 00884838118669: Grid Immobilization Plate LBS M-L
• 00884838118652: Pillar Immobilization Plate LBS C-C
• 00884838118645: Grid Immobilization Plate LBS
• 00884838118621: OBC Grid Immobilization Plate
• 00884838118614: Mammotome Immobilization Plate
• 00884838118607: Pillar Immobilization Plate
• 00884838118591: Grid Immobilization Plate
• 00884838118584: Needle Hub Assembly
• 00884838118577: Fiducial Holder
• 00884838118560: Needle Block Holder
• 00884838118553: MRI Needle Sleeve18G
• 00884838118546: MRI Sleeve Block 16G
• 00884838118539: MRI Needle Sleeve 14G
• 00884838118522: MRI Needle Sleeve 12G
• 00884838118515: MRI Needle Block 18G
• 00884838118508: MRI Needle Block 16G
• 00884838118492: MRI Needle Block 14G
• 00884838118485: MRI Needle Block 12G
• 00884838118478: FIDUCIAL MARKER GRID BLOCK ASSEMBLY
• 00884838118461: Fiducial Marker Sleeve Assembly
• 00884838118454: MRI Needle Block 8G