71161040

GUDID 03596010301796

TITANIUM CANNULATED SCREW 6.5MM X 40MM

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID03596010301796
NIH Device Record Key0e588b2e-3542-4629-bf47-844d839478ea
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71161040
Catalog Number71161040
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exempttrue
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 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
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
GS103596010301796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


[03596010301796]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-22
Device Publish Date2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

00885556891605 - CATALYSTEM2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 4
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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