ContinuTrac™ 438B1178

GUDID M268S438B11781

BUDDE® Halo Ring

INTEGRA LIFESCIENCES CORPORATION

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• Primary Device ID: M268S438B11781
• NIH Device Record Key: 8117cea8-cb25-49dd-b4d4-16494dbca337
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContinuTrac™
• Version Model Number: S438B1178
• Catalog Number: 438B1178
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780355359 [Primary]
HIBCC	M268S438B11781 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830332

FDA Product Code

• GZT: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Sterilization

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

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

[M268S438B11781]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-10-25
• Device Publish Date: 2016-09-29

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