MDM 626-00-48G

GUDID 04546540666031

Liner- Cementless

Howmedica Osteonics Corp.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 04546540666031
• NIH Device Record Key: 9e60292e-6b1f-4a90-993a-1ececa1d884d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDM
• Version Model Number: 626-00-48G
• Catalog Number: 626-00-48G
• 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: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 48 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540666031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103233

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 [MDM]

• 04546540666062: Liner- Cementless
• 04546540666055: Liner- Cementless
• 04546540666048: Liner- Cementless
• 04546540666031: Liner- Cementless
• 04546540666024: Liner- Cementless
• 04546540666017: Liner- Cementless
• 04546540666000: Liner- Cementless
• 04546540665997: Liner- Cementless