FDA.reportPublic FDA data

SurgiTrackSM

Primary DI
10885632527500
Brand
SurgiTrackSM
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
4501879FD7
Device description
General Surgery Tray
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10885632527500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563252750010885632527500

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632539206SurgiTrackSM450041D1852026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815849020917Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022768Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022775Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022782Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022836Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025288Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025493Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025844Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
10198956371019CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956474987CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956504172CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956518629CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956520080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956534520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956535237CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956538375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956539761CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956547322CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956549982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956554016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956555570CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956561281CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956565838CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956569959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956570849CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956582842CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956583061CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956586482CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06