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Guardian®

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name
GUARDIAN® FDA UDI
Generic Name
Knee femur stem prosthesis FDA UDI
Device Name
GUARDIAN® CANAL FILLING STEM 120MM X 14MM FDA UDI
Model / Reference
2500SP14 FDA UDI
Description
GUARDIAN® CANAL FILLING STEM 120MM X 14MM FDA UDI

Identifiers

Catalog Number
2500SP14 FDA UDI
Primary DI / UDI-DI
M6842500SP141 FDA UDI
FDA Product Code
JDI FDA UDI
KRO FDA UDI
GMDN Term
Knee femur stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
888.3510 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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 120 Millimeter FDA UDI

Category: Knee femur stem prosthesisUncoated femoral stem prosthesis, modular

Guardian® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated femoral stem prosthesis, modular.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroPort Orthopedics Inc.

Sources (1)

  • FDA UDI 492188a8-3a05-4a4f-b984-1f7d3678acf4 36 fields · synced Jun 9, 2026