Restrictor B000-1185

GUDID 07613153768258

Universal Cement Restrictor - Disposable Inserter

Howmedica Osteonics Corp.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 07613153768258
• NIH Device Record Key: c443f5fe-cc19-4014-b361-dad0bad516e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restrictor
• Version Model Number: B000-1185
• Catalog Number: B000-1185
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613153768258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924323

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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 [Restrictor]

• 07613153768333: Revision Universal Cement Restrictor- Disposable Inserter
• 07613153768258: Universal Cement Restrictor - Disposable Inserter
• 07613153768210: Revision Universal Cement Restrictor
• 07613153768111: Universal Cement Restrictor
• 04546540007889: Universal Cement Restrictor
• 04546540000279: Universal Cement Restrictor - Disposable Inserter