FDA.reportPublic FDA data

SurgiTrackSM

Primary DI
10885632540639
Brand
SurgiTrackSM
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
450030A8C4
Device description
General Surgery Tray
Published
2026-10-15
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
10885632540639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563254063910885632540639

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
10885632540646SurgiTrackSM450030D0722026-10-15
10885632540615SurgiTrackSM450087ABBD2026-10-13
10885632540059SurgiTrackSM4503872A3B2026-10-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956544017CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956549760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956560765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956566613CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956569966CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956575868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956587267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956590533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956592476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956598126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956599550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956601758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956604209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956606623CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10653160394327MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394334MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394488MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394617MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394969MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394983MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395027MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395171MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395188MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395294MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10809160540657HalyardAVID MEDICAL, INC.LRO2026-10-15
10885632540646SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10653160395287MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395324MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395416MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395423MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14