REAMER HEAD 6.5mm

FDA UDI

Class I (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name: REAMER HEAD 6.5mm FDA UDI
Generic Name: Medullary canal orthopaedic reamer, flexible FDA UDI
Model / Reference: 0223-065 FDA UDI

Identifiers

Primary DI / UDI-DI: 00848665000573 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, flexible 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, flexible

REAMER HEAD 6.5mm by Advanced Orthopaedic Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medullary canal orthopaedic reamer, flexible.

Patella Inlay Reamer Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
World Stem Reamer Size 5-6M — SIGNATURE ORTHOPAEDICS PTY LTD · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Advanced Orthopaedic Solutions, Inc.

Sources (1)

FDA UDI b5b7fa80-d2f8-4bed-b1de-567647dab031 32 fields · synced May 31, 2026