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Gdc-10

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
GDC-10 FDA UDI
Generic Name
Neurovascular embolization coil FDA UDI
Device Name
Ultrasoft Detachable Coil FDA UDI
Model / Reference
M0033434060 FDA UDI
Description
Ultrasoft Detachable Coil FDA UDI

Identifiers

Catalog Number
343406 FDA UDI
Primary DI / UDI-DI
04546540689252 FDA UDI
FDA Product Code
HCG FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 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: Neurovascular embolization coilNon-neurovascular embolization coil

Gdc-10 by Stryker Corp. — 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

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 1be7ae61-2591-4d58-a181-ea4f555bd79e 37 fields · synced May 30, 2026