Blade Plates E0015385-3

GUDID 00885556683538

DRILL GUIDE HANDLE

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting
Primary Device ID00885556683538
NIH Device Record Key942c8aef-c10d-4217-808a-585e42381a22
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlade Plates
Version Model NumberE0015385-3
Catalog NumberE0015385-3
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556683538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


[00885556683538]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2017-02-08

On-Brand Devices [Blade Plates]

00885556683538DRILL GUIDE HANDLE
00885556683521COMPRESSION DRILL GUIDE
00885556683514NEUTRAL DRILL GUIDE

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