Omni-Tract® 11964

GUDID M248119641

Vaginal Posterior Retractor

INTEGRA LIFESCIENCES CORPORATION

Surgical retraction system, reusable
Primary Device IDM248119641
NIH Device Record Keye3fc467b-38e3-4b07-a514-a888d3f7d89c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni-Tract®
Version Model Number11964
Catalog Number11964
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780272830 [Primary]
HIBCCM248119641 [Secondary]

FDA Product Code

FFORETRACTOR, SELF-RETAINING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


[M248119641]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-01-05
Device Publish Date2018-02-23

On-Brand Devices [Omni-Tract®]

M248119641Vaginal Posterior Retractor
M248119621Vaginal Deaver Retractor, Large
M248119581Vaginal Lateral Fixed Retractor, 1in x 3in (2.5cm x 7.6cm)
M248119081Gelpi Point Retractor, Sharp
M24811442P1Kelly Swivel Retractor, Square Shaft, 2in x 3in (5.1cm x 7.6cm)
M24811441P1Harrington Swivel Retractor, Square Shaft, 2.5in x 7.0in (6.3cm x 17.8cm)
M24811355P1GhosTract Tray
M24811121P1Hinged Extension Arm, 19in (48.3cm)
M24810269P1Standard Wishbone Frame Arm
M2483099P1Splanchnic Retractor, 2in x 6in (5.1cm x 15.2cm)
M2483098P1Fence Swivel Blade, 4in x 6in (10.2cm x 15.2cm)
M2483096P1Mayo Retractor, 2-3/4in x 2in (7.0cm x 5.1cm)
M2483093P1Lechner-Harrington Liver Blade, 5in x 3-1/2in (12.7cm x 8.9cm)
M248104981Lower Organizer-Knee
M248118601Omni-Tract® Sterilizer Tray and Cover, Anterior Lumbar Blade Kit
M24835201Omni-Tract® O-Ring, .50in OD x Ø.070in (1.3cm OD x Ø.02cm) Repair Kit
M2483044R1Omni-Tract® Captive Washer, 3/4in (1.9cm) Repair Kit
M2483138RP1Omni-Tract® Deaver Fixed Retractor, 2.7in x 4.5in (7.0cm x 11.4cm)
M248119681Omni-Tract® Perineal Rigid Ring
M248119661Omni-Tract® Perineal Segmented Ring
M248119601Omni-Tract® Omni-Tract Vaginal Deaver Retractor, Small, 1in x 3.5in (2.5cm x 8.9cm)
M248119561Omni-Tract® Renal Vein Fixed Retractor, 1in x 6in (2.5cm x 15.2cm)
M248119541Omni-Tract® Richardson Fixed Retractor, .75in x 1.0in (1.9cm x 2.5cm)
M248119521Omni-Tract® Harrington Sweetheart Fixed Retractor, 3.5in x 10.0in (8.9cm x 25.4cm)
M248119501Omni-Tract® Malleable Fixed Retractor, 2in x 8in (5.1cm x 20.3cm)
M248119481Omni-Tract® Malleable Fixed Retractor, 4in x 8in (10.2cm x 20.3cm)
M248119461Omni-Tract® Malleable Fixed Retractor, 3in x 10in (7.6cm x 25.4cm)
M248119441Omni-Tract® Malleable Fixed Retractor, 2in x 10in (5.1cm x 25.4cm)
M248119421Omni-Tract® Balfour Fixed Retractor, 3.5in x 2.75in (8.9cm x 7.0cm)
M248119401Omni-Tract® Malleable Fixed Retractor, 1in x 5in (2.5cm x 12.7cm)
M248119381Omni-Tract® Malleable Fixed Retractor, .5in x 4in (1.3cm x 10.2cm)
M248119361Omni-Tract® Richardson Fixed Retractor, .75in x 2in (1.9cm x 5.1cm)
M248119331Omni-Tract® Large Nathanson Liver Retractor with Ø.375in (1.0cm) Grasper Tip
M248119321Omni-Tract® Medium Nathanson Liver Retractor with Ø.375in (1.0cm) Grasper Tip
M248119311Omni-Tract® Small Nathanson Liver Retractor with Ø.375in (1.0cm) Grasper Tip
M248119251Omni-Tract® Spineology Tall Access Portal Holder, 21in (53.3cm)
M248119211Omni-Tract® Spineology Speed-Tract® Sterile Field Post
M248119201Omni-Tract® Spineology Support Arm
M248119101Omni-Tract® Standard Blade Clamp
M24811904R1Omni-Tract® Deaver Retractor, Small, .75in x 3.0in (1.9cm x 7.6cm)
M248119021Omni-Tract® Balfour Retractor, Child, 2.25in x 1.5in (5.7cm x 3.8cm)
M248119001Omni-Tract® Richardson Retractor, Child 1in x 1.5in (2.5cm x 3.8cm)
M248118801Omni-Tract® Omni-Flex® Sterile Field Post with Taper Torsion Clamp Assembly
M248118751Omni-Tract® Medium Segmented Ring
M248118681Omni-Tract® Aluminum Renal Retractor, 1in x 8in (2.5cm x 20.3cm) A.B.H.
M248118671Omni-Tract® Aluminum Renal Retractor, 1in x 7in (2.5cm x17.8cm) A.B.H.
M248118661Omni-Tract® Aluminum Renal Retractor, 1in x 6in (2.5cm x 15.2cm) A.B.H.
M248118651Omni-Tract® Aluminum Renal Retractor, 1in x 5in (2.5cm x 12.7cm) A.B.H.
M248118641Omni-Tract® Aluminum Renal Retractor, 1in x 4in (2.5cm x 10.2cm) A.B.H.
M248118631Omni-Tract® Aluminum Renal Retractor, 1in x 3in (2.5cm x 7.6cm) A.B.H.

Trademark Results [Omni-Tract]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNI-TRACT
OMNI-TRACT
73477865 1325588 Live/Registered
Minnesota Scientific, Inc.
1984-04-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.