Omni-Tract® 11946

GUDID M248119461

Omni-Tract® Malleable Fixed Retractor, 3in x 10in (7.6cm x 25.4cm)

INTEGRA LIFESCIENCES CORPORATION

Surgical retraction system, reusable

• Primary Device ID: M248119461
• NIH Device Record Key: f8b9035b-dc3d-4836-bf6a-55f84f924bc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni-Tract®
• Version Model Number: 11946
• Catalog Number: 11946
• 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
• 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	10381780272748 [Primary]
HIBCC	M248119461 [Secondary]

FDA Product Code

• FFO: RETRACTOR, SELF-RETAINING

Sterilization

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

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

[M248119461]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-05-15
• Device Publish Date: 2018-02-23

On-Brand Devices [Omni-Tract®]

• M248119641: Vaginal Posterior Retractor
• M248119621: Vaginal Deaver Retractor, Large
• M248119581: Vaginal Lateral Fixed Retractor, 1in x 3in (2.5cm x 7.6cm)
• M248119081: Gelpi Point Retractor, Sharp
• M24811442P1: Kelly Swivel Retractor, Square Shaft, 2in x 3in (5.1cm x 7.6cm)
• M24811441P1: Harrington Swivel Retractor, Square Shaft, 2.5in x 7.0in (6.3cm x 17.8cm)
• M24811355P1: GhosTract Tray
• M24811121P1: Hinged Extension Arm, 19in (48.3cm)
• M24810269P1: Standard Wishbone Frame Arm
• M2483099P1: Splanchnic Retractor, 2in x 6in (5.1cm x 15.2cm)
• M2483098P1: Fence Swivel Blade, 4in x 6in (10.2cm x 15.2cm)
• M2483096P1: Mayo Retractor, 2-3/4in x 2in (7.0cm x 5.1cm)
• M2483093P1: Lechner-Harrington Liver Blade, 5in x 3-1/2in (12.7cm x 8.9cm)
• M248104981: Lower Organizer-Knee
• M248118601: Omni-Tract® Sterilizer Tray and Cover, Anterior Lumbar Blade Kit
• M24835201: Omni-Tract® O-Ring, .50in OD x Ø.070in (1.3cm OD x Ø.02cm) Repair Kit
• M2483044R1: Omni-Tract® Captive Washer, 3/4in (1.9cm) Repair Kit
• M2483138RP1: Omni-Tract® Deaver Fixed Retractor, 2.7in x 4.5in (7.0cm x 11.4cm)
• M248119681: Omni-Tract® Perineal Rigid Ring
• M248119661: Omni-Tract® Perineal Segmented Ring
• M248119601: Omni-Tract® Omni-Tract Vaginal Deaver Retractor, Small, 1in x 3.5in (2.5cm x 8.9cm)
• M248119561: Omni-Tract® Renal Vein Fixed Retractor, 1in x 6in (2.5cm x 15.2cm)
• M248119541: Omni-Tract® Richardson Fixed Retractor, .75in x 1.0in (1.9cm x 2.5cm)
• M248119521: Omni-Tract® Harrington Sweetheart Fixed Retractor, 3.5in x 10.0in (8.9cm x 25.4cm)
• 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)
• M248119441: Omni-Tract® Malleable Fixed Retractor, 2in x 10in (5.1cm x 25.4cm)
• M248119421: Omni-Tract® Balfour Fixed Retractor, 3.5in x 2.75in (8.9cm x 7.0cm)
• M248119401: Omni-Tract® Malleable Fixed Retractor, 1in x 5in (2.5cm x 12.7cm)
• M248119381: Omni-Tract® Malleable Fixed Retractor, .5in x 4in (1.3cm x 10.2cm)
• M248119361: Omni-Tract® Richardson Fixed Retractor, .75in x 2in (1.9cm x 5.1cm)
• M248119331: Omni-Tract® Large Nathanson Liver Retractor with Ø.375in (1.0cm) Grasper Tip
• M248119321: Omni-Tract® Medium Nathanson Liver Retractor with Ø.375in (1.0cm) Grasper Tip
• M248119311: Omni-Tract® Small Nathanson Liver Retractor with Ø.375in (1.0cm) Grasper Tip
• M248119251: Omni-Tract® Spineology Tall Access Portal Holder, 21in (53.3cm)
• M248119211: Omni-Tract® Spineology Speed-Tract® Sterile Field Post
• M248119201: Omni-Tract® Spineology Support Arm
• M248119101: Omni-Tract® Standard Blade Clamp
• M24811904R1: Omni-Tract® Deaver Retractor, Small, .75in x 3.0in (1.9cm x 7.6cm)
• M248119021: Omni-Tract® Balfour Retractor, Child, 2.25in x 1.5in (5.7cm x 3.8cm)
• M248119001: Omni-Tract® Richardson Retractor, Child 1in x 1.5in (2.5cm x 3.8cm)
• M248118801: Omni-Tract® Omni-Flex® Sterile Field Post with Taper Torsion Clamp Assembly
• M248118751: Omni-Tract® Medium Segmented Ring
• M248118681: Omni-Tract® Aluminum Renal Retractor, 1in x 8in (2.5cm x 20.3cm) A.B.H.
• M248118671: Omni-Tract® Aluminum Renal Retractor, 1in x 7in (2.5cm x17.8cm) A.B.H.
• M248118661: Omni-Tract® Aluminum Renal Retractor, 1in x 6in (2.5cm x 15.2cm) A.B.H.
• M248118651: Omni-Tract® Aluminum Renal Retractor, 1in x 5in (2.5cm x 12.7cm) A.B.H.
• M248118641: Omni-Tract® Aluminum Renal Retractor, 1in x 4in (2.5cm x 10.2cm) A.B.H.
• M248118631: Omni-Tract® Aluminum Renal Retractor, 1in x 3in (2.5cm x 7.6cm) A.B.H.