71070842

GUDID 03596010498373

HANDLE FOR USE WITH 71070840 OR 71070841

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting
Primary Device ID03596010498373
NIH Device Record Key9b186e4a-8519-4015-937b-ae2ada1582e1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71070842
Catalog Number71070842
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 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
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
GS103596010498373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


[03596010498373]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-11-03
Device Publish Date2015-08-25

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