LexTOME MUA00001

GUDID 04589761815338

ACETABULAR REAMER 36mm

MEDMETALEX CO., LTD.

Acetabular orthopaedic reamer

• Primary Device ID: 04589761815338
• NIH Device Record Key: 6d664980-f640-4e99-ad13-84695d468147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LexTOME
• Version Model Number: MUA00001
• Catalog Number: MUA00001
• Company DUNS: 718085432
• Company Name: MEDMETALEX CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589761815338 [Primary]

FDA Product Code

• HTO: Reamer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

[04589761815338]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-25
• Device Publish Date: 2023-04-17

Devices Manufactured by MEDMETALEX CO., LTD.

• 04589761815789 - LexTOME: 2023-10-16 ACETABULAR REAMER STRAIGHT HANDLE
• 04589761818001 - LexTORNADO: 2023-10-10 LexTORNADO Femoral Head Extractor Handle Type
• 04589761818018 - LexTORNADO: 2023-10-10 LexTORNADO Femoral Head Extractor Connect Type, Zimmer End
• 04589761818025 - LexBLADE: 2023-10-10 LexBLADE Single-Edge Chisel, W7/16°/L23cm
• 04589761818032 - LexBLADE: 2023-10-10 LexBLADE Single-Edge Chisel, W8/16°/L23cm
• 04589761818049 - LexBLADE: 2023-10-10 LexBLADE Single-Edge Chisel, W10/16°/L23cm
• 04589761818056 - LexBLADE: 2023-10-10 LexBLADE Single-Edge Chisel, W12/16°/L23cm
• 04589761818063 - LexBLADE: 2023-10-10 LexBLADE Single-Edge Chisel, W15/16°/L23cm