013145

GUDID 03596010024725

FIXATION POST (BOX 1) STR

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID03596010024725
NIH Device Record Key5392d915-e63c-4995-bca4-fa31d9ef46b0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number013145
Catalog Number013145
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010024725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

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 Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

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00885556891612 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 5
00885556891629 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 6
00885556891735 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 4
00885556891742 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED HIGH OFFSET SIZE 5
00885556891759 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 6
00885556892107 - CATALYSTEM2024-08-07 CATALYSTEM BROACH SIZE 0
00885556892114 - CATALYSTEM2024-08-07 CATALYSTEM BROACH SIZE 1

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