71177206

GUDID 03596010601698

6.5/8.0 WASHER SLEEVE 12.7 INTERNAL DIAMETER

Smith & Nephew, Inc.

Orthopaedic implantation sleeve, reusable
Primary Device ID03596010601698
NIH Device Record Key30defcec-0a8d-4005-be28-f0020c7bf881
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71177206
Catalog Number71177206
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
GS103596010601698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

Moist Heat or Steam Sterilization


[03596010601698]

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.

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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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