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Medpor

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
MEDPOR FDA UDI
Generic Name
Surgical implant template, reusable FDA UDI
Device Name
Ext Cont Malar Sizer Set (Sil Non-Ster) FDA UDI
Model / Reference
9952 FDA UDI
Description
Ext Cont Malar Sizer Set (Sil Non-Ster) FDA UDI

Identifiers

Catalog Number
9952 FDA UDI
Primary DI / UDI-DI
07613252086529 FDA UDI
510(k) Number
K922489 FDA UDI
FDA Product Code
FWP FDA UDI
GMDN Term
Surgical implant template, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3550 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Medpor by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K922489 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 59ff2bef-c410-4bd4-9143-06736bbed782 36 fields · synced May 30, 2026