BIOLOX delta 71325176

GUDID 00885556499290

R3 US DELTA HEAD 36 +8

Smith & Nephew, Inc.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis
Primary Device ID00885556499290
NIH Device Record Key9fe47e25-8459-4622-a7a3-c62ee2e6b6b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOLOX delta
Version Model Number71325176
Catalog Number71325176
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

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556499290 [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 Date2017-06-01

On-Brand Devices [BIOLOX delta]

00885556499290R3 US DELTA HEAD 36 +8
00885556499245R3 US DELTA HEAD 36 +4
00885556499191R3 US DELTA HEAD 36 +0
00885556499146R3 US DELTA HEAD 32 +8
00885556499092R3 US DELTA HEAD 32 +4
00885556499047R3 US DELTA HEAD 32 +0
00885556498996R3 36MM ID US DELTA LINER 66 68MM OD
00885556498941R3 36MM ID US DELTA LINER 64MM OD
00885556498897R3 36MM ID US DELTA LINER 62MM OD
00885556498842R3 36MM ID US DELTA LINER 60MM OD
00885556498798R3 36MM ID US DELTA LINER 58MM OD
00885556498743R3 36MM ID US DELTA LINER 56MM OD
00885556498699R3 36MM ID US DELTA LINER 54MM OD
00885556498644R3 36MM ID US DELTA LINER 52MM OD
00885556498590R3 32MM ID US DELTA LINER 50MM OD
00885556498545R3 32MM ID US DELTA LINER 48MM OD
03596010656735BIOLOX DELTA HEAD 40MM 12/14 LONG +8
03596010656728BIOLOX DELTA HEAD 40MM 12/14 MEDIUM +4
03596010656711BIOLOX DELTA HEAD 40MM 12/14 SHORT+0
03596010566966BIOLOX DELTA HEAD 36 MM 12/14 M / +4
03596010566973BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8
03596010566959BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0
03596010566942BIOLOX DELTA HEAD 32 MM 12/14 LONG / +8
03596010566935BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4
03596010566928BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0

Trademark Results [BIOLOX delta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOLOX DELTA
BIOLOX DELTA
85523572 4337105 Dead/Cancelled
CeramTec GmbH
2012-01-24
BIOLOX DELTA
BIOLOX DELTA
79376201 not registered Live/Pending
CeramTec GmbH
2023-07-11
BIOLOX DELTA
BIOLOX DELTA
79180041 5097823 Live/Registered
CeramTec GmbH
2015-10-13
BIOLOX DELTA
BIOLOX DELTA
76689704 3707260 Live/Registered
CERAMTEC GMBH
2008-05-16

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