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
10198956397057CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956408722CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956441798CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956446366CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956471351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956485761CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956492684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956493513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956495425CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956498983CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956500389CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190076MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190137MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190304MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190342MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190380MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190489MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190564MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191066MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01