FDA.reportPublic FDA data

ONETRAC LX

Primary DI
M648C1002601
Brand
ONETRAC LX
Company
OBP CORPORATION
Model
C100260
Device description
Retractor 135X60mm with Built-In Single-Use Multi-LED Light Source - STERILE
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M648C1002601PackageHIBCC1In Commercial Distribution
M648C1002602PackageHIBCC10In Commercial Distribution
M648C1002600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, single-useA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
011560431
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M648C1002500ONETRAC LXC100250C1002502025-07-01
M648C1002501ONETRAC LXC100250C1002502025-07-01
M648C0601000ANOSPEC C060100 C060100 2016-09-21
M648C0601100ANOSPEC C060110 C060110 2016-09-21
M648C0601200ANOSPEC C060120 C060120 2016-09-21
M648C0601002ANOSPEC C060100 C060100 2016-09-21
M648C0601102ANOSPEC C060110 C060110 2016-09-21
M648C0601202ANOSPEC C060120 C060120 2016-09-21
M648C1102100ONETRAC LXSC110210C1102102022-04-15
M648C1102200ONETRAC LXSC110220C1102202022-04-15
M648C1102101ONETRAC LXSC110210C1102102022-04-15
M648C1102201ONETRAC LXSC110220C1102202022-04-15
M648C1002800ONETRAC LXC1002802021-06-02
M648C1002900ONETRAC LXC1002902021-06-02
M648C1002801ONETRAC LXC1002802021-06-02
M648C1002901ONETRAC LXC1002902021-06-02
M648C1102000ONETRAC LXSC110200C1102002021-04-12
M648C1102001ONETRAC LXSC110200C1102002021-04-12
M648C1002020ELBOW CONNECTORC1002022020-10-22
M648C1002021ELBOW CONNECTORC1002022020-10-22

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
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
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
00348783011456Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
00348783011463Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
008401944956533P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956843P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
05060212055323Silicone Bands 2.16mm x 110mm dia x 3DTR MEDICAL LIMITEDGAD2026-06-10
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04