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OrthoMedFlex

FDA UDI

Class I (US FDA UDI)

by Orthomedflex Llc

Identity

Trade Name
OrthoMedFlex FDA UDI
Generic Name
Orthopaedic broach FDA UDI
Device Name
Type A Broach, Size 9 FDA UDI
Model / Reference
111180908 FDA UDI
Description
Type A Broach, Size 9 FDA UDI

Identifiers

Catalog Number
111-18-0908 FDA UDI
Primary DI / UDI-DI
M7161111809080 FDA UDI
FDA Product Code
HTQ FDA UDI
GMDN Term
Orthopaedic broach FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
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

No

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

Yes

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

Category: Orthopaedic broach

OrthoMedFlex by Orthomedflex Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic broach.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthomedflex Llc

Sources (1)

  • FDA UDI eabdc973-f39c-4f66-a288-6faabbfd1afa 34 fields · synced May 29, 2026