Integra® Compact Cranial Closure System CRANCLOSIMP

GUDID M268CRANCLOSIMP1

The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The system offers the operating room surgeon unique features and user friendly capabilities. This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

INTEGRA LIFESCIENCES CORPORATION

Cranioplasty plate, alterable

• Primary Device ID: M268CRANCLOSIMP1
• NIH Device Record Key: 4fb533c3-48f3-4bed-bd91-0a2d7d32b9da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Compact Cranial Closure System
• Version Model Number: CRANCLOSIMP
• Catalog Number: CRANCLOSIMP
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

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 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 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	10381780074359 [Primary]
HIBCC	M268CRANCLOSIMP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112812

FDA Product Code

• HBW: Fastener, Plate, Cranioplasty

Sterilization

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

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

[M268CRANCLOSIMP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-16
• Device Publish Date: 2015-08-15

Devices Manufactured by INTEGRA LIFESCIENCES CORPORATION

• 10381780268536 - Omni-Tract®: 2024-07-18 Omni-Tract® Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75°
• 10381780269106 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 3in (3.8cm x 7.6cm)
• 10381780269113 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 4in (3.8cm x 10.2cm)
• 10381780538134 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, 1.5in x 5in (3.8cm x 12.7cm)
• 10381780538158 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, .75in x 2in (1.9cm x 5.1cm)
• 10381780538165 - Omni-Tract®: 2024-07-18 Omni-Tract® Malleable Swivel Retractor, 1in x 3in (2.5cm x 7.6cm) Mini
• 10381780538172 - Omni-Tract®: 2024-07-18 Omni-Tract® Medial Retractor, 1.5in x 3.5in (3.8cm x 8.9cm)
• 10381780538189 - Omni-Tract®: 2024-07-18 Omni-Tract® Meyerding Retractor, Blunt, 1in x 3in (2.5cm x 7.6cm)