014896

GUDID 03596010026781

SMALL JOINT OSTEOTOME

Smith & Nephew, Inc.

Orthopaedic osteotome
Primary Device ID03596010026781
NIH Device Record Key9fb7851b-c41b-40ba-a082-06eb18360955
Commercial Distribution StatusIn Commercial Distribution
Version Model Number014896
Catalog Number014896
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)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
GS103596010026781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

00885556903438 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 140MM CANNULATED SCREW FULLY THREADED
00885556903445 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 145MM CANNULATED SCREW FULLY THREADED
00885556903452 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 150MM CANNULATED SCREW FULLY THREADED
00885556903469 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 50MM CANNULATED SCREW PARTIALLY THREADED 32MM
00885556903476 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 55MM CANNULATED SCREW PARTIALLY THREADED 32MM
00885556903483 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 60MM CANNULATED SCREW PARTIALLY THREADED 32MM
00885556903490 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 65MM CANNULATED SCREW PARTIALLY THREADED 32MM
00885556903506 - EVOS2025-09-08 EVOS PELVIC 5.0MM X 70MM CANNULATED SCREW PARTIALLY THREADED 32MM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.