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OptiCross 35

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
OptiCross 35 FDA UDI
Generic Name
Intravascular ultrasound imaging catheter, single-use FDA UDI
Device Name
Peripheral Imaging Catheter FDA UDI
Model / Reference
H7493932800350 FDA UDI
Description
Peripheral Imaging Catheter FDA UDI

Identifiers

Catalog Number
H7493932800350 FDA UDI
Primary DI / UDI-DI
08714729984542 FDA UDI
FDA Product Code
ITX FDA UDI
OBJ FDA UDI
GMDN Term
Intravascular ultrasound imaging catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
870.1200 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 8 French FDA UDI

Category: Intravascular ultrasound imaging catheter, single-use

OptiCross 35 by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular ultrasound imaging catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 5e5222ad-5403-428c-9b6d-ad76e39cb12a 35 fields · synced May 30, 2026