Omni-Tract® 3603

GUDID 10381780538158

Omni-Tract® Malleable Swivel Blade with 3/8in (1.0cm) Hole, .75in x 2in (1.9cm x 5.1cm)

INTEGRA LIFESCIENCES CORPORATION

Surgical retraction system, reusable

• Primary Device ID: 10381780538158
• NIH Device Record Key: 2fd3f839-7066-428c-8ba1-a572dd07fb07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni-Tract®
• Version Model Number: 3603
• Catalog Number: 3603
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780269533 [Previous]
GS1	10381780538158 [Primary]

FDA Product Code

• FGN: RETRACTOR, NON-SELF-RETAINING

Sterilization

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

[10381780538158]

Moist Heat or Steam Sterilization

[10381780538158]

Moist Heat or Steam Sterilization

[10381780538158]

Moist Heat or Steam Sterilization

[10381780538158]

Moist Heat or Steam Sterilization

[10381780538158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

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• M2483099P1: Splanchnic Retractor, 2in x 6in (5.1cm x 15.2cm)
• M2483098P1: Fence Swivel Blade, 4in x 6in (10.2cm x 15.2cm)
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• M248119501: Omni-Tract® Malleable Fixed Retractor, 2in x 8in (5.1cm x 20.3cm)
• M248119481: Omni-Tract® Malleable Fixed Retractor, 4in x 8in (10.2cm x 20.3cm)
• M248119461: Omni-Tract® Malleable Fixed Retractor, 3in x 10in (7.6cm x 25.4cm)
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