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ACUITY™ X4 Flushing tool/Wire guide

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
ACUITY™ X4 Flushing tool/Wire guide FDA UDI
Generic Name
Pacing lead implantation adaptor FDA UDI
Device Name
Flushing tool/Wire guide FDA UDI
Model / Reference
4604 FDA UDI
Description
Flushing tool/Wire guide FDA UDI

Identifiers

Primary DI / UDI-DI
00802526527449 FDA UDI
PMA Number
P010012 FDA UDI
FDA Product Code
LWP FDA UDI
GMDN Term
Pacing lead implantation adaptor FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pacing lead implantation adaptor

ACUITY™ X4 Flushing tool/Wire guide by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pacing lead implantation adaptor.

Cleared under the same submission

P010012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 540d3773-6c87-4c35-9db6-79e469012ecc 34 fields · synced May 30, 2026