Modular Cone Reamer, Handle Sleeve

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Modular Cone Reamer, Handle Sleeve FDA UDI
Generic Name: Medullary canal orthopaedic reamer, rigid FDA UDI
Model / Reference: 2019.00.100 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810094691912 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, rigid 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, rigid

Modular Cone Reamer, Handle Sleeve by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI 143fbc12-c570-4d3c-adda-daa724b39088 34 fields · synced May 31, 2026