Aura 107-05-13

GUDID 10885862015334

AURA LG STEM REAMER SZ 3

Exactech, Inc.

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 10885862015334
• NIH Device Record Key: 48c5b42c-ce4b-467b-aa68-3d69322dd1f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aura
• Version Model Number: 107-05-13
• Catalog Number: 107-05-13
• 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: false
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862015334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961304

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

[10885862015334]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [Aura]

• 10885862015563: AURA STEM EXTRACTOR
• 10885862015556: AURA CALCAR CUTTING JIG
• 10885862015549: AURA OSTEOTOMY GUIDE
• 10885862015358: AURA LG STEM REAMER SZ 5
• 10885862015341: AURA LG STEM REAMER SZ 4
• 10885862015334: AURA LG STEM REAMER SZ 3
• 10885862015327: AURA LG STEM REAMER SZ 2
• 10885862015310: AURA REAMER SZ 6
• 10885862015303: AURA REAMER SZ 5
• 10885862015297: AURA REAMER SZ 4
• 10885862015280: AURA REAMER SZ 3
• 10885862015273: AURA REAMER SZ 2
• 10885862015266: AURA REAMER SZ 1
• 10885862015259: AURA REAMER SZ 0
• 10885862015174: AURA PRIMARY BROACH SZ 6
• 10885862015167: AURA PRIMARY BROACH SZ 5
• 10885862015150: AURA PRIMARY BROACH SZ 4
• 10885862015143: AURA PRIMARY BROACH SZ 3
• 10885862015136: AURA PRIMARY BROACH SZ 2
• 10885862015129: AURA PRIMARY BROACH SZ 1
• 10885862015112: AURA PRIMARY BROACH SZ 0
• 10885862015242: AURA NECK TRIAL SZ 6
• 10885862015235: AURA NECK TRIAL SZ 2-5
• 10885862015228: AURA NECK TRIAL SZ 1
• 10885862015532: AURA LONG STEM TRIAL SZ 5, 300 MM
• 10885862015525: AURA LONG STEM TRIAL SZ 4, 300 MM
• 10885862015518: AURA LONG STEM TRIAL SZ 3, 300 MM
• 10885862015501: AURA LONG STEM TRIAL SZ 5, 250 MM
• 10885862015495: AURA LONG STEM TRIAL SZ 4, 250 MM
• 10885862015488: AURA LONG STEM TRIAL SZ 3, 250 MM
• 10885862015471: AURA LONG STEM TRIAL SZ 5, 200 MM
• 10885862015464: AURA LONG STEM TRIAL SZ 4, 200 MM
• 10885862015457: AURA LONG STEM TRIAL SZ 3, 200 MM
• 10885862015440: AURA LONG STEM TRIAL SZ 5, 165 MM
• 10885862015433: AURA LONG STEM TRIAL SZ 4, 165 MM
• 10885862015426: AURA LONG STEM TRIAL SZ 3, 165 MM
• 10885862015211: AURA LONG STEM BROACH SZ 5, 165MM
• 10885862015204: AURA LONG STEM BROACH SZ 4, 165MM
• 10885862015198: AURA LONG STEM BROACH SZ 3, 165MM
• 10885862015181: AURA LONG STEM BROACH SZ 2, 165MM