FDA.reportPublic FDA data

NA

Primary DI
00849771052708
Brand
NA
Company
KEY SURGICAL, INC.
Model
Plastic Sterilization Tray
Catalog number
PST1100SB
Device description
Plastic Sterilization Tray with Slotted Base and Silicone Mat; 7.5-inch x 2.5-inch x 0.75-inch 190.5 x 63.5 x 19mm
Published
2023-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00849771029656PreviousGS10
00849771052708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771029656008497710296568497710296560849771029656
00849771052708008497710527088497710527080849771052708

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"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
604056226
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
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
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
00849771048626NAPlastic Sterilization TraysPST3300SB2023-05-08
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
10198956309012CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956404243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956437159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956489134CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956495579CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956495616CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956501607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956501850CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
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