FDA.reportPublic FDA data

ONETRAC LXD

Primary DI
M648C1002700
Brand
ONETRAC LXD
Company
OBP CORPORATION
Model
C100270
Published
2020-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
M648C1002701PackageHIBCC1In Commercial Distribution
M648C1002702PackageHIBCC10In Commercial Distribution
M648C1002700PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
9782916853REGULATORY@OBPMED.COM

Regulatory Flags#

DUNS number
011560431
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
00846159040548SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040555SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040579SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040586SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040593SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
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
00846159040388SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040395SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040401SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040418SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040432SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040449SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040456SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040463SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040470SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040487SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040494SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040500SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040517SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03