FDA.reportPublic FDA data

Omni-Tract®

Primary DI
10381780268598
Brand
Omni-Tract®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
3098
Catalog number
3098
Device description
Omni-Tract® Fence Swivel Blade, 4in x 6in (10.2cm x 15.2cm)
Published
2018-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFORETRACTOR, SELF-RETAINING
FGNRETRACTOR, NON-SELF-RETAINING
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780268598PrimaryGS10
M24830981SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178026859810381780268598

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
963856096
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
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00846159040609SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040616SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040623SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00841536147230ThompsonThompson Surgical Instruments, Inc.GAD2026-06-03
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00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
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00846159040500SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040517SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040272SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040289SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040296SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040302SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02