Novation Element 165-10-16

GUDID 10885862249333

BROACH, NOVATION ELEMENT, SIZE 16

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862249333
• NIH Device Record Key: 0ca69dc7-611e-4c63-982c-aa6bafbbf2cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novation Element
• Version Model Number: 165-10-16
• Catalog Number: 165-10-16
• 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	10885862249333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080980

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

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

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

Moist Heat or Steam Sterilization

[10885862249333]

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 Element]

• 10885862280633: NV ELEMENT STARTER RASP SZ 8 WITH CHIP BREAKERS
• 10885862280626: NV ELEMENT STARTER RASP SZ 7 WITH CHIP BREAKERS
• 10885862249357: BROACH, NOVATION ELEMENT, SIZE 18
• 10885862249340: BROACH, NOVATION ELEMENT, SIZE 17
• 10885862249333: BROACH, NOVATION ELEMENT, SIZE 16
• 10885862249326: BROACH, NOVATION ELEMENT, SIZE 15
• 10885862249319: BROACH, NOVATION ELEMENT, SIZE 14
• 10885862249302: BROACH, NOVATION ELEMENT, SIZE 13
• 10885862249296: BROACH, NOVATION ELEMENT, SIZE 12
• 10885862249289: BROACH, NOVATION ELEMENT, SIZE 11
• 10885862249272: BROACH, NOVATION ELEMENT, SIZE 10
• 10885862249265: BROACH, NOVATION ELEMENT, SIZE 9
• 10885862249258: BROACH, NOVATION ELEMENT, SIZE 8
• 10885862204165: NV ELEM RO NT X/O SZ 13 NECK TRIAL
• 10885862204141: NV ELEM RO NT X/O SZ 11 NECK TRIAL
• 10885862204134: NV ELEM RO NT X/O SZ 10 NECK TRIAL
• 10885862204127: NV ELEM RO NT X/O SZ 9 NECK TRIAL
• 10885862204110: NV ELEM RO NT X/O SZ 8 NECK TRIAL
• 10885862204103: NV ELEM RO NT S/O SZ 13 NECK TRIAL
• 10885862204097: NV ELEM RO NT S/O SZ 12 NECK TRIAL
• 10885862204073: NV ELEM RO NT S/O SZ 10 NECK TRIAL
• 10885862204066: NV ELEM RO NT S/O SZ 9 NECK TRIAL
• 10885862204059: NV ELEM RO NT S/O SZ 8 NECK TRIAL
• 10885862035721: TEMPLATE, STEM, SIZE 8-18
• 10885862035691: TRIAL, NECK, EXTENDED OFFSET, SIZE 14-18
• 10885862035684: TRIAL, NECK, EXTENDED OFFSET, SIZE 11-13
• 10885862035677: TRIAL, NECK, EXTENDED OFFSET, SIZE 8-10
• 10885862035660: TRIAL, NECK, SIZE 14-18
• 10885862035653: TRIAL, NECK, SIZE 11-13
• 10885862035646: TRIAL, NECK, SIZE 8-10
• 10885862035639: BROACH, SIZE 18
• 10885862035622: BROACH, SIZE 17
• 10885862035615: BROACH, SIZE 16
• 10885862035608: BROACH, SIZE 15
• 10885862035592: BROACH, SIZE 14
• 10885862035585: BROACH, SIZE 13
• 10885862035578: BROACH, SIZE 12
• 10885862035561: BROACH, SIZE 11
• 10885862035547: BROACH, SIZE 9
• 10885862035530: BROACH, SIZE 8
• 10885862035394: TEMPLATE, SIZE 08/18