FDA.reportPublic FDA data

NA

Primary DI
00849771048626
Brand
NA
Company
KEY SURGICAL, INC.
Model
Plastic Sterilization Trays
Catalog number
PST3300SB
Device description
Plastic Sterilization Tray with Slotted Base, Insert Tray and 2 Silicone Mat, 10.0-inch x 6.0-inch x 1.5-inch 254 x 152 x 38mm
Published
2023-05-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00849771029694PreviousGS10
00849771048626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771029694008497710296948497710296940849771029694
00849771048626008497710486268497710486260849771048626

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
604056226
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26
00849771048619NAPlastic Sterilization TrayPST3200SB2023-01-26
00849771052692NAPlastic Sterilization TrayPST0100SB2023-01-26
00849771052715NAPlastic Sterilization TrayPST3200SBC12023-01-26
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
10849771050374NASilicone Clamp CoversVS2012023-03-31
10849771050381NASilicone Clamp CoverVS2022023-01-26
10849771050398NASilicone Clamp CoverVS2032023-01-26
00849771031284Key Surgical Silicone Clamp CoversVS-103VS1032020-12-09
00849771048367NASurgical Plastic InstrumentKS3472023-01-26
00849771048374NASurgical Plastic InstrumentsKS3482023-04-04
10849771013379Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
10849771047428NAInstrument OrganizerCSDH1002022-11-22
10849771047435NAInstrument OrganizerCSDH1022022-11-22
10849771047442NAInstrument OrganizerCSDH1052022-11-22
10849771047459NAInstrument OrganizerCSDH3002022-11-22
10849771047466NAInstrument OrganizerCSDH2002022-11-22
10849771047473NAInstrument OrganizerCSDH5052022-11-22
10849771047480NAInstrument OrganizerCSDH5122022-11-22

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