546002000

GUDID 10603295174318

CEMENT RESTRICTOR INSERTER

DEPUY ORTHOPAEDICS, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10603295174318
• NIH Device Record Key: d8a30f2a-724a-40a3-9a9c-6270b1f86d6f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5460-02-000
• Catalog Number: 546002000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295174318 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

[10603295174318]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-24

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

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• 10603295552635 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE ASSEMBLY 6 - 8
• 10603295552703 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE ASSEMBLY 3 - 5
• 10603295552789 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 2.0 mm
• 10603295552840 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 3.0 mm
• 10603295552857 - RECLAIM: 2025-08-05 RECLAIM TM MAKE TO ORDER NECK TRIAL SO
• 10603295553465 - RECLAIM: 2025-08-05 RECLAIM TM MAKE TO ORDER NECK TRIAL HO
• 10603295553472 - ATTUNETM: 2025-08-05 ATTUNETM MAKE TO ORDER FEMORAL TRIAL SHIM 1mm THICK