← Back to catalogue

Complex Helical - 18

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Complex Helical - 18 FDA UDI
Generic Name
Non-neurovascular embolization coil FDA UDI
Device Name
Fibered Platinum Coil FDA UDI
Model / Reference
M0013120330 FDA UDI
Description
Fibered Platinum Coil FDA UDI

Identifiers

Catalog Number
M0013120330 FDA UDI
Primary DI / UDI-DI
08714729201175 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Non-neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Category: Non-neurovascular embolization coil

Complex Helical - 18 by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-neurovascular embolization coil.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 4f865cfc-4807-44dc-8779-be3fb15df7b5 35 fields · synced May 30, 2026