Novation Ceramic AHS 140-01-54

GUDID 10885862025241

Exactech, Inc.

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: 10885862025241
• NIH Device Record Key: e1637fd1-d870-44e8-b681-b4086957fc0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novation Ceramic AHS
• Version Model Number: 140-01-54
• Catalog Number: 140-01-54
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 54 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862025241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050039

FDA Product Code

• MRA: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or 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: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2014-09-01

On-Brand Devices [Novation Ceramic AHS]

• 10885862026507: 141-36-45
• 10885862026491: 141-36-44
• 10885862026484: 141-36-43
• 10885862026422: 141-32-42
• 10885862026361: 141-28-41
• 10885862026057: 141-00-21
• 10885862026040: 141-00-20
• 10885862026033: 141-00-19
• 10885862026026: 141-00-18
• 10885862026019: 141-00-17
• 10885862026002: 141-00-16
• 10885862025999: 141-00-15
• 10885862025982: 141-00-14
• 10885862025975: 141-00-13
• 10885862025968: 141-00-12
• 10885862279125: 140-11-68
• 10885862279118: 140-11-66
• 10885862279101: 140-11-64
• 10885862279095: 140-11-62
• 10885862279088: 140-11-60
• 10885862279071: 140-11-58
• 10885862279064: 140-11-56
• 10885862279057: 140-11-54
• 10885862279040: 140-11-52
• 10885862279033: 140-11-50
• 10885862279026: 140-11-48
• 10885862025319: 140-01-68
• 10885862025302: 140-01-66
• 10885862025296: 140-01-64
• 10885862025289: 140-01-62
• 10885862025272: 140-01-60
• 10885862025265: 140-01-58
• 10885862025258: 140-01-56
• 10885862025241: 140-01-54
• 10885862025234: 140-01-52
• 10885862025227: 140-01-50
• 10885862025210: 140-01-48
• 10885862027221: 143-36-15
• 10885862027214: 143-36-14
• 10885862027207: 143-36-13
• 10885862027139: 143-32-12
• 10885862027078: 143-28-11
• 10885862026101: 141-01-15
• 10885862026095: 141-01-14
• 10885862026088: 141-01-13
• 10885862026071: 141-01-12
• 10885862026064: 141-01-11
• 10885862025548: 140-36-15
• 10885862025531: 140-36-14
• 10885862025524: 140-36-13