Bone Plug B003-0140

GUDID 04546540007919

Sized Cement Plug

Howmedica Osteonics Corp.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 04546540007919
• NIH Device Record Key: c7e3b990-c3d4-4f5a-b839-01937cd9934c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Plug
• Version Model Number: B003-0140
• Catalog Number: B003-0140
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540007919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926216

FDA Product Code

• LTO: SPACER, CEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Bone Plug]

• 07613327036695: Canal -Cemented
• 07613327036671: Canal -Cemented
• 07613327036664: Canal -Cemented
• 07613153768371: Sized Cement Plug
• 04546540007957: Sized Cement Plug
• 04546540007940: Sized Cement Plug
• 04546540007933: Sized Cement Plug
• 04546540007926: Sized Cement Plug
• 04546540007919: Sized Cement Plug
• 04546540007902: Sized Cement Plug
• 04546540007896: Sized Cement Plug