Invivo

FDA UDI

Class II (US FDA UDI)

by Philips DS North America LLC

Identity

Trade Name: Invivo FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: Biopsy Grid (User-sterilized) FDA UDI
Model / Reference: 459801508641 FDA UDI
Description: Biopsy Grid (User-sterilized) FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838081734 FDA UDI
FDA Product Code: MOS FDA UDI
GMDN Term: MRI system coil, radio-frequency FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: MRI system coil, radio-frequency

Invivo by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system coil, radio-frequency.

Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
All-Purpose Arch — NORAS MRI products GmbH · Class II
LEYLA Retractor Socket — NORAS MRI products GmbH · Class II
16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
All-Purpose Arch Adapter — NORAS MRI products GmbH · Class II
Operator's Manual Flexibility Siemens — NORAS MRI products GmbH · Class II
NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Philips DS North America LLC

Sources (1)

FDA UDI 34b87325-31b3-4053-b774-49332dfd3bbe 35 fields · synced Jun 8, 2026