Omnifit 2042-2846

GUDID 04546540036124

20degrees Series II Insert

Howmedica Osteonics Corp.

Constrained polyethylene acetabular liner

• Primary Device ID: 04546540036124
• NIH Device Record Key: b1b0a6ef-77df-4e1b-9196-b5a519cba86b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnifit
• Version Model Number: 2042-2846
• Catalog Number: 2042-2846
• 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

• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540036124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943054

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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 [Omnifit]

• 07613327140736: 0 Degree Series II Insert
• 07613327101676: Acetabular Cup
• 07613327101362: 0 Degree Series II Insert
• 07613327101355: 0 Degree Series II Insert
• 07613327101348: 0 Degree Series II Insert
• 07613327101331: 0 Degree Series II Insert
• 07613327101324: 0 Degree Series II Insert
• 07613327101317: 0 Degree Series II Insert
• 07613327101300: 0 Degree Series II Insert
• 07613327101294: 0 Degree Series II Insert
• 07613327101287: 0 Degree Series II Insert
• 07613327101263: 10 Degree Series II Insert
• 07613327101256: 10 Degree Series II Insert
• 07613327101232: 10 Degree Series II Insert
• 07613327101225: 10 Degree Series II Insert
• 07613327101218: 10 Degree Series II Insert
• 07613327101195: 10 Degree Series II Insert
• 07613327039160: 127 Degree Cemented Hip Stem
• 07613327039153: 127 Degree Cemented Hip Stem
• 07613327039146: 127 Degree Cemented Hip Stem
• 07613327039139: 127 Degree Cemented Hip Stem
• 07613327039122: 127 Degree Cemented Hip Stem
• 07613327039115: 127 Degree Cemented Hip Stem
• 07613327039108: 127 Degree Cemented Hip Stem
• 07613327038545: Acetabular Cup
• 07613327038538: Acetabular Cup
• 07613327038521: Acetabular Cup
• 07613327038514: Acetabular Cup
• 07613327038507: Acetabular Cup
• 07613327038491: Acetabular Cup
• 07613327038484: Acetabular Cup
• 07613327038477: Acetabular Cup
• 07613327038460: Acetabular Cup
• 07613327038453: Acetabular Cup
• 07613327038446: Acetabular Cup
• 07613327038439: Acetabular Cup
• 07613327038422: Acetabular Cup
• 07613327038415: Acetabular Cup
• 07613327038408: Acetabular Cup
• 07613327038392: Acetabular Cup
• 07613327038385: Acetabular Cup
• 07613327038378: Acetabular Cup
• 07613327038361: Acetabular Cup
• 07613327038354: Acetabular Cup
• 07613327038347: Hip Stem
• 07613327038330: Hip Stem
• 07613327038323: Hip Stem
• 07613327038316: Hip Stem
• 07613327038309: Hip Stem
• 07613327038293: Hip Stem