ContinuTrac™ 438B1178

GUDID M268S438B11781

BUDDE® Halo Ring

INTEGRA LIFESCIENCES CORPORATION

Neurosurgical retraction system, brain
Primary Device IDM268S438B11781
NIH Device Record Key8117cea8-cb25-49dd-b4d4-16494dbca337
Commercial Distribution StatusIn Commercial Distribution
Brand NameContinuTrac™
Version Model NumberS438B1178
Catalog Number438B1178
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780355359 [Primary]
HIBCCM268S438B11781 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-10-25
Device Publish Date2016-09-29

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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)

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