Instrument Set 9095.10.543

GUDID 08033390057592

Trial Head LOW Taper=12/14 Dia=40 mm - L

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 08033390057592
• NIH Device Record Key: 65ac5975-36a3-47f8-9f0c-9b82ba687967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument Set
• Version Model Number: Trial Head
• Catalog Number: 9095.10.543
• 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
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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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390057592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112898

FDA Product Code

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

Sterilization

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

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

Moist Heat or Steam Sterilization

[08033390057592]

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 [Instrument Set]

• 08033390057608: Trial Head LOW Taper=12/14 Dia=40 mm - XL
• 08033390057592: Trial Head LOW Taper=12/14 Dia=40 mm - L
• 08033390057585: Trial Head LOW Taper=12/14 Dia=40 mm - M
• 08033390057578: Trial Head LOW Taper=12/14 Dia=40 mm - S
• 08033390022484: Trial Head LOW Taper=12/14 Dia=36 mm - XL
• 08033390021685: Trial Head LOW Taper=12/14 Dia=28 mm - L
• 08033390021678: Trial Head LOW Taper=12/14 Dia=28 mm - M
• 08033390021661: Trial Head LOW Taper=12/14 Dia=28 mm - S
• 08033390021470: Trial Head LOW Taper=12/14 Dia=36 mm - L
• 08033390021463: Trial Head LOW Taper=12/14 Dia=36 mm - S
• 08033390021395: Trial Head LOW Taper=12/14 Dia=32 mm - L
• 08033390021388: Trial Head LOW Taper=12/14 Dia=32 mm - S
• 08033390021142: Trial Head LOW Taper=12/14 Dia=36 mm - M
• 08033390021135: Trial Head LOW Taper=12/14 Dia=32 mm - M
• 08033390064972: Offset Femoral Elevator
• 08033390064965: Femoral Elevator
• 08033390064958: Single Pronge Narrow Hohmann Retrac (25mm)
• 08033390064941: Single Pronge Large Hohmann Retrac. (35mm)
• 08033390064934: Cobra Style Hohmann Retractor
• 08033390064927: Incision Ruler