FDA.reportPublic FDA data

Medichoice

Primary DI
10885632111358
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GU1001
Device description
Tray General Utility Pocono Medical Center MediChoice
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
50885632111356PackageGS120In Commercial Distribution
10885632111358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563211135650885632111356
1088563211135810885632111358

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00avoid freezing and excessive heat

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632524936SurgiTrackSM450087A18C2026-07-09
10885632524943SurgiTrackSM4500872B162026-07-09
10885632524882SurgiTrackSM4500877C312026-07-08
10885632524899SurgiTrackSM45008780392026-07-08
10885632524905SurgiTrackSM45008766152026-07-08
10885632524912SurgiTrackSM45008762622026-07-08
10885632524929SurgiTrackSM450087F5C22026-07-08
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632524790SurgiTrackSM450087D8CD2026-06-25
10885632524721SurgiTrackSM450070DAF72026-06-24
10885632524738SurgiTrackSM450071932C2026-06-24
10885632523267SurgiTrackSM45008746332026-06-10
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956074668CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956119260CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956286719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956483675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956485068CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956490956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491496CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491953CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956492219CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956492615CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956493902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494558CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956496996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497450CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497696CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09