Trial Head 9095.10.723

GUDID 08033390084000

Trial Head #L D=32mm - Taper 12/14

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 08033390084000
• NIH Device Record Key: ed484ad6-ceed-4558-8921-f82f1905fbd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Head
• Version Model Number: Trial Head
• Catalog Number: 9095.10.723
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390084000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112898

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

[08033390084000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-12-21
• Device Publish Date: 2016-08-05

On-Brand Devices [Trial Head]

• 08033390084093: Trial Head #XL D=40mm - Taper 12/14
• 08033390084086: Trial Head #L D=40mm - Taper 12/14
• 08033390084079: Trial Head #M D=40mm - Taper 12/14
• 08033390084062: Trial Head #S D=40mm - Taper 12/14
• 08033390084055: Trial Head #XL D=36mm - Taper 12/14
• 08033390084048: Trial Head #L D=36mm - Taper 12/14
• 08033390084031: Trial Head #M D=36mm - Taper 12/14
• 08033390084024: Trial Head #S D=36mm - Taper 12/14
• 08033390084017: Trial Head #XL D=32mm - Taper 12/14
• 08033390084000: Trial Head #L D=32mm - Taper 12/14
• 08033390083997: Trial Head #M D=32mm - Taper 12/14
• 08033390083980: Trial Head #S D=32mm - Taper 12/14
• 08033390083973: Trial Head #XL D=28mm - Taper 12/14
• 08033390083966: Trial Head #L D=28mm - Taper 12/14
• 08033390083959: Trial Head #M D=28mm - Taper 12/14
• 08033390083942: Trial Head #S D=28mm - Taper 12/14