FDA.reportPublic FDA data

ONETRAC LX

Primary DI
M648C1002200
Brand
ONETRAC LX
Company
OBP CORPORATION
Model
C100220
Device description
Retractor 175x30mm with Built-In Single-Use Multi-LED Light Source - STERILE
Published
2019-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
M648C1002201PackageHIBCC1In Commercial Distribution
M648C1002202PackageHIBCC10In Commercial Distribution
M648C1002200PrimaryHIBCC0

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.

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
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00810143904659SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904680SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904697SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904703SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904710SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904727SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904918SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904956SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905045SURGIPROSSurgipros, LLCGAD2026-07-30