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Reusable Pointer Instruments

EUDAMEDFDA UDI

Class I (EU MDR)

Ref SYN-0642

by Synaptive Medical Inc.

Identity

Trade Name
Reusable Pointer Instruments EUDAMED
BrightMatter Pointer FDA UDI
Generic Name
Neurological stereotactic surgery system FDA UDI
Device Name
Standard Pointer EUDAMED
Model / Reference
SYN-0642 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00670082000092 EUDAMEDFDA UDI
Basic UDI-DI
67008200005LR EUDAMED
Direct Marketing DI
00670082000092 EUDAMED
510(k) Number
K160523 FDA UDI
K183325 FDA UDI
FDA Product Code
HAW FDA UDI
EMDN Code
L031199 PROBES AND MIRRORS, REUSABLE - OTHER EUDAMED
GMDN Term
Neurological stereotactic surgery system FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Reusable Pointer Instruments by Synaptive Medical Inc — 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
Synaptive Medical Inc.
EUDAMED SRN
CA-MF-000010705
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED b58fbf5d-a2d7-43dd-9576-b998a3a8decd 61 fields · synced Jun 18, 2026
  • FDA UDI cc377fa8-c298-4133-a0a6-9aec4206b963 33 fields · synced May 30, 2026