Omniflex 6046-1035

GUDID 07613153324393

Hip Stem

Howmedica Osteonics Corp.

Press-fit femoral stem prosthesis

• Primary Device ID: 07613153324393
• NIH Device Record Key: 5c21aa59-d593-4bb4-a199-72edac44f541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omniflex
• Version Model Number: 6046-1035
• Catalog Number: 6046-1035
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613153324393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911585

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

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 [Omniflex]

• 07613327012750: Smooth Collar Femoral Stem
• 07613327012743: Smooth Collar Femoral Stem
• 07613327012736: Smooth Collar Femoral Stem
• 07613327012729: Smooth Collar Femoral Stem
• 07613327012712: Smooth Collar Femoral Stem
• 07613327012705: Smooth Collar Femoral Stem
• 07613327012699: Smooth Collar Femoral Stem
• 07613327012682: Smooth Collar Femoral Stem
• 07613327012675: Smooth Collar Femoral Stem
• 07613327012668: Smooth Collar Femoral Stem
• 07613327012644: Smooth Collar Femoral Stem
• 07613153324423: Hip Stem
• 07613153324416: Hip Stem
• 07613153324409: Hip Stem
• 07613153324393: Hip Stem
• 07613153324386: Hip Stem
• 07613153324379: Hip Stem
• 07613153324362: Hip Stem
• 07613153324355: Hip Stem
• 07613153324348: Hip Stem
• 07613153324331: Hip Stem