Novation 161-05-05

GUDID 10885862033635

NV TAPERED REAMER SZ5

Exactech, Inc.

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 10885862033635
• NIH Device Record Key: 9f443610-e76d-4cfe-b25d-5b3d6e2845c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novation
• Version Model Number: 161-05-05
• Catalog Number: 161-05-05
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862033635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042842

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

[10885862033635]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [Novation]

• 10885862249432: 180-03-52
• 10885862244437: 186-03-68
• 10885862244420: 186-03-66
• 10885862244413: 186-03-64
• 10885862244406: 186-03-62
• 10885862244390: 186-03-60
• 10885862244383: 186-03-58
• 10885862244376: 186-03-56
• 10885862244369: 186-03-54
• 10885862244352: 186-03-52
• 10885862244345: 186-03-50
• 10885862244338: 186-03-48
• 10885862233288: 186-00-68
• 10885862233271: 186-00-66
• 10885862233264: 186-00-64
• 10885862233257: 186-00-62
• 10885862233240: 186-00-60
• 10885862233233: 186-00-58
• 10885862233226: 186-00-56
• 10885862233219: 186-00-54
• 10885862233202: 186-00-52
• 10885862233196: 186-00-50
• 10885862233189: 186-00-48
• 10885862220554: 186-02-68
• 10885862220547: 186-02-66
• 10885862220530: 186-02-64
• 10885862220523: 186-02-62
• 10885862220516: 186-02-60
• 10885862220509: 186-02-58
• 10885862220493: 186-02-56
• 10885862220486: 186-02-54
• 10885862220479: 186-02-52
• 10885862220462: 186-02-50
• 10885862220455: 186-02-48
• 10885862038852: 186-01-68
• 10885862038845: 186-01-66
• 10885862038838: 186-01-64
• 10885862038821: 186-01-62
• 10885862038814: 186-01-60
• 10885862038807: 186-01-58
• 10885862038791: 186-01-56
• 10885862038784: 186-01-54
• 10885862038777: 186-01-52
• 10885862038760: 186-01-50
• 10885862038753: 186-01-48
• 10885862037770: 180-14-54
• 10885862037763: 180-13-68
• 10885862037756: 180-13-66
• 10885862037749: 180-13-64
• 10885862037732: 180-13-62