FDA.report

Klassic HD Hip Case 1, Miscellaneous Hip Instruments

Primary DI
00819251021883
Brand
Klassic HD Hip Case 1, Miscellaneous Hip Instruments
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
1401.00.000
Device description
Hip Case 1, Miscellaneous Hip Instruments
Published
2019-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819251021883PrimaryGS10

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags

DUNS number
078416717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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