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Wedge 10 CF ExaFix™

FDA UDI

Class II (US FDA UDI)

by Macromedics B.v.

Identity

Trade Name
Wedge 10 CF ExaFix™ FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Carbon fiber wedge, fit for ExaFix,10 degrees FDA UDI
Model / Reference
CFW10 FDA UDI
Description
Carbon fiber wedge, fit for ExaFix,10 degrees FDA UDI

Identifiers

Catalog Number
110550 FDA UDI
Primary DI / UDI-DI
08719425700953 FDA UDI
510(k) Number
K142420 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Wedge 10 CF ExaFix™ by Macromedics B.v. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142420 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Macromedics B.v.

Sources (1)

  • FDA UDI 81484dfe-90ab-4f25-89dc-b81a639b427b 36 fields · synced May 31, 2026