FDA.reportPublic FDA data

Key Surgical Plastic Sterilization Trays

Primary DI
00849771033431
Brand
Key Surgical Plastic Sterilization Trays
Company
KEY SURGICAL, INC.
Model
PST-3200SBC-1
Device description
Plastic Sterilization Tray w/Slotted Base & Silicone Mat; 254 x 152 x 38mm
Published
2020-12-11
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
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
00849771033431PrimaryGS10
00849771052715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771033431008497710334318497710334310849771033431
00849771052715008497710527158497710527150849771052715

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical 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 may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide;Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com
+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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849771052708NAPlastic Sterilization TrayPST1100SB2023-01-26
00849771052159NAES50ES502023-01-26
00849771048237NAK-Wire and Steinmann Pin DispenserKI710172025-08-11
00849771049036NAK-Wires and Steinmann PinsKI711312025-08-11
00849771049289NAK-Wires and Steinmann PinsKI711852025-08-11
00849771049500NAK-Wires and Steinmann PinsKI712532025-08-11
00849771048169NAK-Wire and Steinmann Pin DispensersKI710022025-04-30
00849771049012NAK-Wires and Steinmann PinsKI711242025-04-30
00849771049128NAK-Wires and Steinmann PinsKI711612025-04-30
60849771050416Electro LubeEL101EL1012025-04-24
00849771046356K-Wire and Steinmann Pin DispensersKI71042KI710422025-04-16
00849771046363K-Wire and Steinmann Pin DispensersKI71044KI710442025-04-16
00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
00849771046387K-Wire and Steinmann Pin DispensersKI71047KI710472025-04-16
00849771046394K-Wire and Steinmann Pin DispensersKI71048KI710482025-04-16
00849771013372Key Surgical Cautery Tip CleanerTC200NSTC200NS2025-04-04
50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
00849771048190NAK-Wire and Steinmann Pin DispensersKI710062024-10-03
00849771052562Key Surgical Pipe CleanersPC100CPC100C2024-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956258730CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956350205CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956378162CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956402843CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956460690CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956461840CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956470613CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956482159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956488533CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956491236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956492998CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
10198956494824CARDINAL HEALTHCardinal Health 200, LLCLRP2026-05-25
04046826447953Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495923Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
04046826495978Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-03-24
50198956435382CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-24
50198956248968CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956284027CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956293043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956304954CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956305630CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956308433CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956313703CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956322590CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956325607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956331677CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956332292CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956348255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23
50198956356526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-03-23