Bipolar Hip System 1914-0-0053

GUDID 00840286841214

Bipolar Head Trial, 28 mm, Sz 53

Shalby Advanced Technologies, Inc.

Femoral head prosthesis trial
Primary Device ID00840286841214
NIH Device Record Keya24039af-709e-4698-94a0-e9fd44de4382
Commercial Distribution StatusIn Commercial Distribution
Brand NameBipolar Hip System
Version Model Number1914-0-0053
Catalog Number1914-0-0053
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
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 Usefalse
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

Customer Support Contacts

Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286841214 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

[00840286841214]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-30
Device Publish Date2025-05-22

On-Brand Devices [Bipolar Hip System]

00840286854016Bipolar Head Trial, 28 mm, Sz 41
00840286854009Bipolar Head Trial, 28 mm, Sz 40
00840286853996Bipolar Head Trial, 28mm, Size 39
00840286853989Bipolar Head Trial, 28 mm, Sz 38
00840286841566Bipolar Femoral Head Trial, 22mm, Sz 56
00840286841559Bipolar Femoral Head Trial, 22mm, Sz 55
00840286841542Bipolar Femoral Head Trial, 22mm, Sz 54
00840286841535Bipolar Femoral Head Trial, 22mm, Sz 53
00840286841528Bipolar Femoral Head Trial, 22mm, Sz 52
00840286841511Bipolar Femoral Head Trial, 22mm, Sz 51
00840286841504Bipolar Femoral Head Trial, 22mm, Sz 50
00840286841498Bipolar Femoral Head Trial, 22mm, Sz 49
00840286841481Bipolar Femoral Head Trial, 22mm, Sz 48
00840286841474Bipolar Femoral Head Trial, 22mm, Sz 47
00840286841467Bipolar Femoral Head Trial, 22mm, Sz 46
00840286841450Bipolar Femoral Head Trial, 22mm, Sz 45
00840286841443Bipolar Femoral Head Trial, 22mm, Sz 44
00840286841436Bipolar Femoral Head Trial, 22mm, Sz 43
00840286841429Bipolar Femoral Head Trial, 22mm, Sz 42
00840286841412Bipolar Femoral Head Trial, 22mm, Sz 41
00840286841405Bipolar Femoral Head Trial, 22mm, Sz 40
00840286841399Bipolar Femoral Head Trial, 22mm, Sz 39
00840286841382Bipolar Femoral Head Trial, 22mm, Sz 38
0084028684137522mm Bipolar Trial Handle
00840286841368Bipolar Insert Removal Tool (22mm), Sz 54, 55, 56
00840286841351Bipolar Insert Removal Tool (22mm), Sz 51, 52, 53
00840286841344Bipolar Insert Removal Tool (22mm), Sz 48, 49, 50
00840286841337Bipolar Insert Removal Tool (22mm), Sz 45, 46, 47
00840286841320Bipolar Insert Removal Tool (22mm), Sz 42, 43, 44
00840286841313Bipolar Insert Removal Tool (22mm), Sz 38, 39, 40, 41
00840286841306Bipolar Head Trial, 28 mm, Sz 62
00840286841290Bipolar Head Trial, 28 mm, Sz 61
00840286841283Bipolar Head Trial, 28 mm, Sz 60
00840286841276Bipolar Head Trial, 28 mm, Sz 59
00840286841269Bipolar Head Trial, 28 mm, Sz 58
00840286841252Bipolar Head Trial, 28 mm, Sz 57
00840286841245Bipolar Head Trial, 28 mm, Sz 56
00840286841238Bipolar Head Trial, 28 mm, Sz 55
00840286841221Bipolar Head Trial, 28 mm, Sz 54
00840286841214Bipolar Head Trial, 28 mm, Sz 53
00840286841207Bipolar Head Trial, 28 mm, Sz 52
00840286841191Bipolar Head Trial, 28 mm, Sz 51
00840286841184Bipolar Head Trial, 28 mm, Sz 50
00840286841177Bipolar Head Trial, 28 mm, Sz 49
00840286841160Bipolar Head Trial, 28 mm, Sz 48
00840286841153Bipolar Head Trial, 28 mm, Sz 47
00840286841146Bipolar Head Trial, 28 mm, Sz 46
00840286841139Bipolar Head Trial, 28 mm, Sz 45
00840286841122Bipolar Head Trial, 28 mm, Sz 44
00840286841115Bipolar Head Trial, 28 mm, Sz 43
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