FDA.reportPublic FDA data

SurgiTrackSM

Primary DI
10885632414497
Brand
SurgiTrackSM
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
4500417C93
Device description
General Surgery Tray
Published
2023-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885632414497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563241449710885632414497

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632539039SurgiTrackSM450087473B2026-09-25
10885632538902SurgiTrackSM450048BAEE2026-09-24
10885632537066SurgiTrackSM4501483A7F2026-09-18
10885632537110SurgiTrackSM450070CC682026-09-18
10885632532665SurgiTrackSM450087F5342026-09-04
10885632532726SurgiTrackSM450041DB622026-09-04
10885632531781SurgiTrackSM450071D8E02026-08-26
10885632531842SurgiTrackSM450059D7A22026-08-26
10885632531644SurgiTrackSM45008770E72026-08-25
10885632531361SurgiTrackSM450370A2B92026-08-21
10885632530845SurgiTrackSM4500879EF72026-08-19
10885632530852SurgiTrackSM4500874A9D2026-08-19
10885632530869SurgiTrackSM45008740342026-08-19
10885632530876SurgiTrackSM4500874A7F2026-08-19
10885632530883SurgiTrackSM450087A9BA2026-08-19
10885632530913SurgiTrackSM450087265F2026-08-19
10885632530135SurgiTrackSM4500454DAC2026-08-14
10885632530142SurgiTrackSM45037076DC2026-08-14
10885632530159SurgiTrackSM45037089B12026-08-14
10885632530166SurgiTrackSM45037046602026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459760846MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-09-25
10198956172715CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956339729CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956393288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956461086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956462205CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956511286CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956520608CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956534308CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956541931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956549357CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956551541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956552791CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956554047CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956558700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561038CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956567788CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568426CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568433CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956569379CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956572522CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573734CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573857CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956574366CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956576568CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25