FDA.report

Key Surgical Plastic Sterilization Trays

Primary DI
00849771029656
Brand
Key Surgical Plastic Sterilization Trays
Company
KEY SURGICAL, INC.
Model
PST-1100SB
Device description
Plastic Sterilization Tray w/Slotted Base & Silicone Mat; 7.5" x 2.5" x 0.75" (190.5 x 63.5 x 19mm)
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

Related Records

Contact Domains

Product Codes

CodeName
LRPTray, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849771029656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771029656008497710296568497710296560849771029656

GMDN Terms

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
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts

PhoneEmail
800.541.7995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

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

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00849771046370K-Wire and Steinmann Pin DispensersKI71046KI710462025-04-16
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50849771050617NAK-Wire and Pin CoversC1092025-01-29
10724995225022Electro LubeEL201EL2012024-10-03
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