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MRI Needle Block 12G

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989603203464

by Philips Medical Systems Nederland B.V.

Identity

Trade Name
MRI Needle Block 12G EUDAMED
Philips FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
Breast Biopsy Devices PMS Sterile EUDAMED
MRI Needle Block 12G FDA UDI
Model / Reference
989603203464 EUDAMED
Needle Block 12G FDA UDI
Description
MRI Needle Block 12G FDA UDI

Identifiers

Catalog Number
989603203464 FDA UDI
Primary DI / UDI-DI
00884838118485 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM841TG EUDAMED
FDA Product Code
GDF FDA UDI
EMDN Code
A018002 NEEDLE GUIDES EUDAMED
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4800 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

MRI Needle Block 12G by Philips Medical Systems Nederland B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.
EUDAMED SRN
NL-MF-000001489

Sources (2)

  • EUDAMED 1f79489c-3bad-46b7-8b98-0f1a1a0160f5 61 fields · synced Oct 5, 2026
  • FDA UDI 45d7a969-0f9b-4430-b601-6c906daa67d8 36 fields · synced May 30, 2026