FDA.reportPublic FDA data

bio-tray

Primary DI
00850045406592
Brand
bio-tray
Company
General Hospital Supply Corp
Model
BT-1121
Catalog number
BT-1121
Device description
Transport Tray
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045406592PrimaryGS10
10850045406599Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045406592008500454065928500454065920850045406592
1085004540659910850045406599

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, single-useA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a single-use device.

Regulatory Flags#

DUNS number
055852834
Device count
50
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045406035rack-n-stack011701172022-09-14
00850045406011rack-n-stack010801082022-09-14
00850045406004rack-n-stack010201022022-09-12
10850045406599bio-trayBT-1121BT-11212024-08-15
00850045406585triple-liner602260222023-08-17
10850045406582triple-liner602260222023-08-17
00850045406028rack-n-stack011201122022-09-14
00850045406257fold-n-hold089508952022-09-20
00850045406264fold-n-hold081208122022-09-20
00850045406271fold-n-hold050505052022-09-20
00850045406288fold-n-hold041704172022-09-20
00850045406295fold-n-hold101010102022-09-20
00850045406387plasma-tazzS0607S06072022-09-20
00850045406394plasma-tazzS0810S08102022-09-20
00850045406400plasma-tazzS3511S35112022-09-20
00850045406417plasma-tazzS3517S35172022-09-20
00850045406424count-me-outCMO-10CMO-102022-09-20
00850045406431count-me-outCMO-11CMO-112022-09-20
00850045406448count-me-outCMO-15CMO-152022-09-20
00850045406455count-me-outCMO-16CMO-162022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956520790CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956521001CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956568228CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569348CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956569843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956570009CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956570801CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956571396CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
10198956571402CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-26
03661219289265LANDANGERLANDANGERLRP2026-08-23
04054462922260evonosevonos GmbH & Co. KGLRP2026-08-18
10198956523852CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-18
10198956289475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956512252CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956554474CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956557468CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956558908CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
10198956559172CARDINAL HEALTHCardinal Health 200, LLCLRP2026-08-17
04054462921102evonosevonos GmbH & Co. KGLRP2026-08-14
04054462921119evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922277evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922284evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922307evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922314evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922338evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922369evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922376evonosevonos GmbH & Co. KGLRP2026-08-14
04054462922383evonosevonos GmbH & Co. KGLRP2026-08-14
03661219288992LANDANGERLANDANGERLRP2026-08-09
03661219289050LANDANGERLANDANGERLRP2026-08-09