FDA.reportPublic FDA data

SurgiTrackSM

Primary DI
10885632541773
Brand
SurgiTrackSM
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
4500592B80
Device description
General Surgery Tray
Published
2026-10-27
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
10885632541773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563254177310885632541773

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
10885632542213SurgiTrackSM450070F8442026-10-28
10885632520341HALYARDABCP10052026-10-27
10885632520358HALYARDABCP10042026-10-27
10885632541131SurgiTrackSM45005945612026-10-22
10885632417122Halyard555702026-10-21
10885632417146Halyard555722026-10-21
10885632520327HALYARDABC10102026-10-21
10885632520334HALYARDABC10122026-10-21
20885632532129HALYARDABCP10062026-10-21
10885632540776SurgiTrackSM450387ABDC2026-10-19
10885632540844SurgiTrackSM45016406752026-10-19
10885632540851SurgiTrackSM450164E9E92026-10-19
10885632540639SurgiTrackSM450030A8C42026-10-15
10885632540646SurgiTrackSM450030D0722026-10-15
10885632540615SurgiTrackSM450087ABBD2026-10-13
10885632540059SurgiTrackSM4503872A3B2026-10-07
10885632539206SurgiTrackSM450041D1852026-09-29
10885632539039SurgiTrackSM450087473B2026-09-25
10885632538902SurgiTrackSM450048BAEE2026-09-24
10885632537066SurgiTrackSM4501483A7F2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542064HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542071HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542088HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542095HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542163HALYARDAVID MEDICAL, INC.LRO2026-10-28
10809160542170HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542194HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-28
10809160542200HalyardAVID MEDICAL, INC.LRO2026-10-28
10885632542213SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-28
10809160541784HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541791HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541838HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541845HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541852HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541869HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541883HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541913HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541937HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541951HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541975HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541982HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160541999HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10809160542002HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-27
10198956515376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956577282CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956578869CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956590359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956592902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956596214CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956603752CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26