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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
External orthopaedic fixation system reprocessed component FDA UDI
Device Name
394.89 @CARBON FIBER ROD 11MM X 500MM FDA UDI
Model / Reference
39489RH FDA UDI
Description
394.89 @CARBON FIBER ROD 11MM X 500MM FDA UDI

Identifiers

Catalog Number
39489RH FDA UDI
Primary DI / UDI-DI
10080196692910 FDA UDI
510(k) Number
K171911 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system reprocessed component FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: External orthopaedic fixation system reprocessed component

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system reprocessed component.

Cleared under the same submission

K171911 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI fac1424c-540d-427b-80f8-dbee19d7f102 36 fields · synced Jun 6, 2026