FDA.reportPublic FDA data

SurgiTrackSM

Primary DI
10885632524844
Brand
SurgiTrackSM
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
45004133CC
Device description
General Surgery Tray
Published
2026-07-06
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
10885632524844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563252484410885632524844

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
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05
10885632522659SurgiTrackSM4501306C1C2026-06-05
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956261952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956331235CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956393424CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956427198CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956445864CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956456969CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956473072CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956477209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956487161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956493773CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956494619CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956497443CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498747CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956499553CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956502765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504820CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956508897CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956509221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956510081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956515505CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956524576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525351CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525825CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525924CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10809160526156HALYARDAVID MEDICAL, INC.LRO2026-07-06