FDA.reportPublic FDA data

Omni-Tract®

Primary DI
10381780268666
Brand
Omni-Tract®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
3121R
Catalog number
3121R
Device description
Omni-Tract® Deaver Fixed Retractor, 4in x 5.5in (10.2cm x 14.0cm)
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
10381780268666PrimaryGS10
M2483121R1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178026866610381780268666

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
Length5.5Inch
Length14Centimeter
Width4Inch
Width10.2Centimeter

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
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
10381780072256Integra Mishler Dual Chamber Flushing ValveNL8500312NL85003122015-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404239MillenniumAvalign Technologies, Inc.GAD2026-07-24
00190776422042MillenniumAvalign Technologies, Inc.GAD2026-07-24
00190776422103MillenniumAvalign Technologies, Inc.GAD2026-07-24
00190776422134MillenniumAvalign Technologies, Inc.GAD2026-07-24
B382SD907394200Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9141051110Surgical DirectSurgical Direct, Inc.FGN2026-07-24
B382SD914172160Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141731000Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141781300Surgical DirectSurgical Direct, Inc.GAD2026-07-24
00190776421977MillenniumAvalign Technologies, Inc.GAD2026-07-23
B382SD155310120Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD155310140Surgical DirectSurgical Direct, Inc.FGN2026-07-23
B382SD1553600Surgical DirectSurgical Direct, Inc.FGN2026-07-23
00198506091926ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
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B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22