BIOLOX FORTE CERAMIC 71330324

GUDID 00885556021248

BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +4

Smith & Nephew, Inc.

Ceramic femoral head prosthesis
Primary Device ID00885556021248
NIH Device Record Key93648d40-4d1e-4c4b-86fc-1fb00c4a631d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOLOX FORTE CERAMIC
Version Model Number71330324
Catalog Number71330324
Company DUNS109903521
Company NameSmith & Nephew, Inc.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556021248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-05-06

On-Brand Devices [BIOLOX FORTE CERAMIC]

00885556021644BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +8
00885556021248BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +4
00885556020869BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +0
00885556020838BIOLOX FORTE CERAMIC 28MM FEM HEAD 12/14 TAPER +0
00885556020531BIOLOX FORTE US FEMORAL HEAD 36MM L/+8 12/14 TPR
00885556020241BIOLOX FORTE US FEMORAL HEAD 36MM M+4 12/14 TPR +4
00885556019993BIOLOX FORTE CERAMIC 28MM FEMORAL HEAD 12/14 TPR +8
00885556019849BIOLOX FORTE US FEMORAL HEAD 36MM S/+0 12/14 TPR
00885556019726BIOLOX FORTE CERAMIC 28MM FEM HEAD 12/14 TAPER +4

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