FDA.report

StelKast Generic Knee instruments

Primary DI
10840843127482
Brand
StelKast Generic Knee instruments
Company
Stelkast Incorporated
Model
SC4042
Device description
GenFlex2 Insert Tray- Femoral Trial
Published
2019-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSMTray, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840843127482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084084312748210840843127482

GMDN Terms

TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1(724)-941-6368customer_service@stelkast.com

Regulatory Flags

DUNS number
804792265
Device count
1
DM exempt
true
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 DIBrandModelCatalogPublished
10840843100157Provident Hip SystemSC1217-462015-03-03
10840843100164Provident Hip SystemSC1217-482015-04-15
10840843100171Provident Hip SystemSC1217-502015-04-15
10840843100188Provident Hip SystemSC1217-522015-04-15
10840843100195Provident Hip SystemSC1217-542015-04-15
10840843100201Provident Hip SystemSC1217-562015-04-15
10840843100218Provident Hip SystemSC1217-582015-04-15
10840843100225Provident Hip SystemSC1217-602015-04-15
10840843100232Provident Hip SystemSC1217-622015-04-15
10840843100249Provident Hip SystemSC1217-642015-04-15
10840843100256Provident Hip SystemSC1217-662015-04-15
10840843100263Provident Hip SystemSC1217-682015-04-15
10840843100270Provident Hip SystemSC1217-702015-04-15
10840843100287Provident Hip SystemSC1217-722015-04-15
10840843100805Zirconia Ceramic HeadSC1405-28mm +0M2015-10-07
10840843100812Zirconia Ceramic HeadSC1405-28mm +3.5 L2015-10-07
10840843100829Zirconia Ceramic HeadSC1405-28mm -3.5 S2015-10-07
10840843100836Zirconia Ceramic HeadSC1406-28mm +7 XL2015-10-07
10840843100843Proform Hip SystemSC1408-100-462015-02-17
10840843100850Proform Hip SystemSC1408-100-482015-02-17

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