FDA.reportPublic FDA data

SurgiTrackSM

Primary DI
10885632058103
Brand
SurgiTrackSM
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
45004421C3
Device description
General Surgery Tray
Published
2016-10-11
Public version status
Update
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
10885632058103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563205810310885632058103

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain 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
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
10198956328457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956348189CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956380127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956383647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956387287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956388406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956413757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956416802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956426146CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956427242CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956430174CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956437265CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956441910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956444775CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956445680CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956453753CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956455528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956456624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457096CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457713CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956460638CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956461741CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956462014CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956463516CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956464360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465831CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465855CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25