FDA.reportPublic FDA data

HypoPan

Primary DI
00860010987926
Brand
HypoPan
Company
TyTek Medical Inc.
Model
1009
Device description
Autoclave pan and tray for Surgical HypoHolder
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860010987926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010987926008600109879268600109879260860010987926

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078589992
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010987902Surgical HypoHolder10032025-06-27
00860010987940Clinical HypoHolder10042025-06-27
00860013471606HypoFoam10002025-06-17
00855204008006TPAKTM-303TM-3032019-10-03
00855204008013TVACTM-909TM-9092019-10-03
00855204008020Ptensys Bleeding Control StationTM-400TM-4002019-10-03
00855204008037Ptensys Bleeding Control KitsTM-401TM-4012019-10-03
00855204008051TPAKTM-310TM-3102019-10-03
00855204008068TYTEK TRAUMA BANDAGETM-204TM-2042019-10-03
00855204008075TYTEK TRAUMA BANDAGETM-206TM-2062019-10-03
00855204008082TYTEK TRAUMA BANDAGETM-212TM-2122019-10-03
00855204008099EZ GAUZETM-215TM-2152019-10-03
00855204008167PneumoDartTM-317TM-3172019-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956558793CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956572447CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956578470CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956589575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956599901CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956604216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611450CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611863CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956617384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956619241CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
00810161900992EARP, IMPLANT CADDY 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901005EARP, IMPLANT LID 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901012EARP, IMPLANT CADDY 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901029EARP, IMPLANT LID 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901036EARP, IMPLANT CADDY 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901043EARP, IMPLANT LID 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901050EARP, IMPLANT CADDY 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901067EARP, IMPLANT LID 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901074EARP, IMPLANT CADDY 18X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901081EARP, IMPLANT LID 18X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901098EARP, IMPLANT CADDY 18X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901104EARP, IMPLANT LID 18X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901111EARP, IMPLANT CADDY 18X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901128EARP, IMPLANT LID 18X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901135EARP, IMPLANT CADDY 18X45RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901142EARP, IMPLANT CADDY 18X50RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901159EARP, IMPLANT CADDY 22X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901166EARP, IMPLANT LID 22X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901173EARP, IMPLANT CADDY 22X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901180EARP, IMPLANT LID 22X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16