Titan Humeral Resurfacing Arthroplasty TRL-900-56/21

GUDID 00885556837535

HRA TRIAL SZ. 56/21

Smith & Nephew, Inc.

Humeral head prosthesis trial, reusable
Primary Device ID00885556837535
NIH Device Record Key259d3b8c-75eb-47ca-bad4-e5a683537173
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitan Humeral Resurfacing Arthroplasty
Version Model NumberTRL-900-56/21
Catalog NumberTRL-900-56/21
Company DUNS045483575
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 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(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
GS100885556837535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

[00885556837535]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2022-12-22

On-Brand Devices [Titan Humeral Resurfacing Arthroplasty]

00885556837450HUMERAL SIZER/CENTRALIZER SZ. 56-21
00885556837443HUMERAL SIZER/CENTRALIZER SZ. 52-21
00885556837436HUMERAL SIZER/CENTRALIZER SZ. 52-18
00885556837429HUMERAL SIZER/CENTRALIZER SZ. 48-20
00885556837412HUMERAL SIZER/CENTRALIZER SZ. 48-17
00885556837405HUMERAL SIZER/CENTRALIZER SZ. 44-18
00885556837399HUMERAL SIZER/CENTRALIZER SZ. 44-15
00885556837382HUMERAL SIZER/CENTRALIZER SZ. 40-16
00885556837283HRA IMPACTOR
00885556837191HRA CENTER DRILL SZ. 3
00885556837184HRA CENTER DRILL SZ. 2
00885556837177HRA CENTER DRILL SZ. 1
00885556837122HUMORAL BROACH SZ. 3
00885556837115HUMORAL BROACH SZ. 2
00885556837108HUMORAL BROACH SZ. 1
00885556837085HRA ADAPTER SZ. 3
00885556837078HRA ADAPTER SZ. 2
00885556837061HRA ADAPTER SZ. 1
00885556831007KOLBEL RETRACTOR BLADE X-LARGE
00885556830994KOLBEL RETRACTOR BLADE SMALL
00885556830987KOLBEL RETRACTOR BLADE LARGE
00885556830949GLENOID RETRACTOR SMALL
00885556830932GLENOID RETRACTOR LARGE
00885556830901DARRACH RETRACTOR SMALL
00885556830895DARRACH RETRACTOR LARGE
00885556837276HRA COMPONENT SZ. 56/21
00885556837269HRA COMPONENT SZ. 52/21
00885556837252HRA COMPONENT SZ. 52/18
00885556837245HRA COMPONENT SZ. 48/20
00885556837238HRA COMPONENT SZ. 48/17
00885556837221HRA COMPONENT SZ. 44/18
00885556837214HRA COMPONENT SZ. 44/15
00885556837207HRA COMPONENT SZ. 40/16
00885556837535HRA TRIAL SZ. 56/21
00885556837528HRA TRIAL SZ. 52/21
00885556837511HRA TRIAL SZ. 52/18
00885556837504HRA TRIAL SZ. 48/20
00885556837498HRA TRIAL SZ. 48/17
00885556837481HRA TRIAL SZ. 44/18
00885556837474HRA TRIAL SZ. 44/15
00885556837467HRA TRIAL SZ. 40/16
00885556837375HRA SHAPER SZ. 56/21
00885556837368HRA SHAPER SZ. 52/21
00885556837351HRA SHAPER SZ. 52/18
00885556837344HRA SHAPER SZ. 48/20
00885556837337HRA SHAPER SZ. 48/17
00885556837320HRA SHAPER SZ. 44/18
00885556837313HRA SHAPER SZ. 44/15
00885556837306HRA SHAPER SZ. 40/16
00885556837160HRA BOTTOM TRAY
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