71932995

GUDID 00885556058442

SHORT TAPER STEM PC STD SIZE 11

Smith & Nephew, Inc.

Press-fit femoral stem prosthesis
Primary Device ID00885556058442
NIH Device Record Keyd8944d20-073e-4155-bf78-3054dfedde98
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71932995
Catalog Number71932995
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)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556058442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

00885556901687 - Q-FIX2024-10-14 Q-FIX KNOTLESS ALL-SUTURE ANCHOR 1.8MM WITH ONE ULTRABRAID SUTURE BLUE
00885556900567 - LEGION/GII2024-09-18 PATELLA CAPTURE ROUND/OVAL 29MM
00885556900574 - LEGION/GII2024-09-18 PATELLA CAPTURE ROUND/OVAL 32MM
00885556900581 - LEGION/GII2024-09-18 PATELLA CAPTURE ROUND/OVAL 35MM
00885556900598 - LEGION/GII2024-09-18 PATELLA CAPTURE ROUND/OVAL 38MM
00885556900604 - LEGION/GII2024-09-18 PATELLA CAPTURE ROUND/OVAL 41MM
00885556900611 - LEGION/GII2024-09-18 PATELLA CLAMP ATTACHMENT
00885556900628 - LEGION/GII2024-09-18 PATELLA SECONDARY SCREW CLAMP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.