Invivo

Basic Information

• Brand Name: Invivo
• Primary DI: 00884838115255
• Version / Model: 9896-031-10735
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 009237140
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-20
• Public Version: 3
• Public Version Date: 2023-12-06
• Public Version Status: Update
• Public Device Record Key: d4128aa2-fe8e-4f5a-b331-ebcda31a2492

Device Description

BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assemblies; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 LBS C-C Grid Immobilization Plates Sterilized; 3 LBS C-C Pillar Immobilization Plates Sterilized; 2 Biopsy Fiducial Markers; MRI Needle Sleeve 16G; Fiducial Marker Block; 2 Needle Block Holder.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOS	Coil, Magnetic Resonance, Specialty	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838115255	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius