71364010

GUDID 03596010199263

SLAP HAMMER

Smith & Nephew, Inc.

Surgical mallet
Primary Device ID03596010199263
NIH Device Record Key682d72a0-babe-4f2a-ac3d-63481ee3d900
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71364010
Catalog Number71364010
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)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
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
GS103596010199263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDGProsthesis, hip, femoral component, cemented, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


[03596010199263]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

00885556905470 - NA2025-03-12 VARIABLE ANGLE VALGUS GUIDE
00885556880876 - EVOS2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE
00885556880883 - EVOS2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE
00885556886403 - EVOS2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL
00885556886410 - EVOS2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - LARGE
23596010587682 - FOOTPRINT2025-01-10 REPLACEMENT END CAPS FOR MALLET SET OF 2
00885556905463 - NA2024-12-25 INSERT TRIAL PITCHFORK
00885556915288 - NA2024-12-25 LM/RL TIBIA ALIGNMENT GUIDE SHORT

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