FDA.reportPublic FDA data

Omni-Tract®

Primary DI
10381780268437
Brand
Omni-Tract®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
11182
Catalog number
11182
Device description
"Omni-Tract® Heaney Retractor 10-1/2"", Blade 1-1/8"" X 3"" Deep"
Published
2018-10-23
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
10381780268437PrimaryGS10
M248111821SecondaryHIBCC0
00381780268430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178026843710381780268437
00381780268430003817802684303817802684300381780268430

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
12
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09
00888937033663ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
B382SD484610Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484630Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484640Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484650Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484660Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484670Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484680Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484690Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484700Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484710Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484720Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD9147091620Surgical DirectSurgical Direct, Inc.FFO2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
B803NL97020450ORTHOMEDORTHO-MED, INC.FGN2026-06-25
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
00192896123540Green RetractorSONTEC INSTRUMENTS, INC.GAD2026-06-24
00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23