Titan Modular Shoulder System 2.5 BOD-0923-020-10LRG

GUDID 00885556859407

TSS PRIMARY PROXIMAL BODY. 2.5 10LRG

Smith & Nephew, Inc.

Shoulder humeral body prosthesis
Primary Device ID00885556859407
NIH Device Record Key82a6d6e3-66c2-4155-9369-be58c6837ee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan Modular Shoulder System 2.5
Version Model NumberBOD-0923-020-10LRG
Catalog NumberBOD-0923-020-10LRG
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556859407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-17
Device Publish Date2022-12-22

On-Brand Devices [Titan Modular Shoulder System 2.5]

00885556863459TAPER DISASSEMBLY TOOL
00885556863398TSS DEFINITIVE STEM FRACTURE BODY TRIAL STD. 2.5
00885556863381TSS DEFINITIVE STEM FRACTURE BODY TRIAL SML. 2.5
00885556863374TSS DEFINITIVE STEM FRACTURE BODY TRIAL LRG. 2.5
00885556863367TSS FRACTURE BODY TRIAL STD. 2.5
00885556863350TSS FRACTURE BODY TRIAL SML. 2.5
00885556863343TSS FRACTURE BODY TRIAL LRG. 2.5
00885556863336TSS HEAD TRIAL ECCENTRIC. 2.5 52X20MM
00885556863329TSS HEAD TRIAL CONCENTRIC. 2.5 52X20MM
00885556863312TSS HEAD TRIAL ECCENTRIC. 2.5 50X22MM
00885556863305TSS HEAD TRIAL CONCENTRIC. 2.5 50X22MM
00885556863299TSS HEAD TRIAL ECCENTRIC. 2.5 50X19MM
00885556863282TSS HEAD TRIAL CONCENTRIC. 2.5 50X19MM
00885556863275TSS HEAD TRIAL ECCENTRIC. 2.5 48X21MM
00885556863268TSS HEAD TRIAL CONCENTRIC. 2.5 48X21MM
00885556863251TSS HEAD TRIAL ECCENTRIC. 2.5 48X18MM
00885556863244TSS HEAD TRIAL CONCENTRIC. 2.5 48X18MM
00885556863237TSS HEAD TRIAL ECCENTRIC. 2.5 48X15MM
00885556863220TSS HEAD TRIAL CONCENTRIC. 2.5 48X15MM
00885556863213TSS HEAD TRIAL ECCENTRIC. 2.5 46X20MM
00885556863206TSS HEAD TRIAL CONCENTRIC. 2.5 46X20MM
00885556863190TSS HEAD TRIAL ECCENTRIC. 2.5 46X17MM
00885556863183TSS HEAD TRIAL CONCENTRIC. 2.5 46X17MM
00885556863176TSS HEAD TRIAL ECCENTRIC. 2.5 46X14MM
00885556863169TSS HEAD TRIAL CONCENTRIC. 2.5 46X14MM
00885556863152TSS HEAD TRIAL ECCENTRIC. 2.5 44X19MM
00885556863145TSS HEAD TRIAL CONCENTRIC. 2.5 44X19MM
00885556863138TSS HEAD TRIAL ECCENTRIC. 2.5 44X16MM
00885556863121TSS HEAD TRIAL CONCENTRIC. 2.5 44X16MM
00885556863114TSS HEAD TRIAL ECCENTRIC. 2.5 42X16MM
00885556863107TSS HEAD TRIAL CONCENTRIC. 2.5 42X16MM
00885556863091TSS HEAD TRIAL ECCENTRIC. 2.5 40X15MM
00885556863084TSS HEAD TRIAL ECCENTRIC. 2.5 38X14MM
00885556862261TSS STEM IMPACTION STAND
00885556862254TAPER ADAPTER SHAFT
00885556862193BODY SEPARATOR
00885556862162HEAD CUTTING GUIDE
00885556862155HEAD EXTRACTOR
00885556862032HEAD IMPACTION STAND. BASE ASSEMBLY
00885556861912TSS HEAD CUTTING TEMPLATE ROD. 2.5
00885556861745TSS TRIAL CALCAR PLANER. 2.5
00885556861608FIN-LOCK PUNCH
00885556861592GLENOID PEGGED PUNCH MED/LG
00885556861585GLENOID PEGGED PUNCH XSM/SM
00885556861578GLENOID KEELED PUNCH MED/LG
00885556861561GLENOID KEELED PUNCH XSM/SM
00885556861516MONOBLOCK HUMERAL SOUNDER. 16 MM
00885556861509MONOBLOCK HUMERAL SOUNDER. 15 MM
00885556861493MONOBLOCK HUMERAL SOUNDER. 14 MM
00885556861486MONOBLOCK HUMERAL SOUNDER. 13 MM

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