BiPolar Hip System

GUDID 10840843102410

Stelkast Incorporated

Bipolar femoral head outer component, hemiarthroplasty
Primary Device ID10840843102410
NIH Device Record Keye89e4b97-abe4-47c9-8175-42d2db50c1e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiPolar Hip System
Version Model NumberSC1866-42/22
Company DUNS804792265
Company NameStelkast Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110840843102410 [Primary]

FDA Product Code

KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-09-09
Device Publish Date2014-12-29

On-Brand Devices [BiPolar Hip System]

10840843102649SC1866-65/28
10840843102632SC1866-64/28
10840843102625SC1866-63/28
10840843102618SC1866-62/28
10840843102601SC1866-61/28
10840843102595SC1866-60/28
10840843102588SC1866-59/28
10840843102571SC1866-58/28
10840843102564SC1866-57/28
10840843102557SC1866-56/28
10840843102540SC1866-55/28
10840843102533SC1866-54/28
10840843102526SC1866-53/28
10840843102519SC1866-52/28
10840843102502SC1866-51/28
10840843102496SC1866-50/28
10840843102489SC1866-49/28
10840843102472SC1866-48/28
10840843102465SC1866-47/28
10840843102458SC1866-46/28
10840843102441SC1866-45/28
10840843102434SC1866-44/22
10840843102427SC1866-43/22
10840843102410SC1866-42/22
10840843102403SC1866-41/22
10840843102397SC1866-40/22
10840843102380SC1866-39/22

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