FDA.reportPublic FDA data

bio-tray

Primary DI
10850045406599
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055852834
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00850045406592bio-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
00816611026649AngioSystems TrayANGIOSYSTEMS, INCORPORATEDLRP2026-09-22
10198956446953CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956486294CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956520240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956570191CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578371CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956579644CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588042CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588868CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588875CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589070CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589148CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589155CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589483CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589636CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956590342CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956591561CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592834CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592995CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593312CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593329CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594067CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594456CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594708CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956587861CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-21