Seitz Solution Unlar Head KCUS-5254

GUDID B033KCUS5254

52x5x4mm Stem

Kapp Surgical Instrument Co.

Wrist ulna-head prosthesis
Primary Device IDB033KCUS5254
NIH Device Record Keya68097bb-5282-4282-b288-286a9a4c87e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeitz Solution Unlar Head
Version Model NumberKCUS-5254
Catalog NumberKCUS-5254
Company DUNS004171112
Company NameKapp Surgical Instrument Co.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB033KCUS5254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXEProsthesis, Wrist, Hemi-, Ulnar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B033KCUS5254]

Moist Heat or Steam Sterilization


[B033KCUS5254]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [Seitz Solution Unlar Head]

B033KCUS527652x7.5x6.5mm Stem
B033KCUS526552x6.5x5.5mm Stem
B033KCUS525452x5x4mm Stem
B033KCUH161716.5x17mm Ulnar Head
B033KCUH151515x15.5mm Ulnar Head
B033KCUH131413.5x14mm Ulnar Head
B033KCUC487648x7.5x6.5mm Collard Stem
B033KCUC486548x6.5x5.5.5mm Collared Stem
B033KCUC485448x5x4mm Collared Stem
B033KCS727.5x2mm Spacer
B033KCS717.5x1mm Spacer
B033KCS626.5x2mm Spacer
B033KCS616.5x1mm Spacer
B033KCS525x2mm Spacer
B033KCS515x1mm Spacer

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