111454

GUDID 03596010038999

HOKE OSTEOTOME 7.9MM X 127MM

Smith & Nephew, Inc.

Orthopaedic osteotome
Primary Device ID03596010038999
NIH Device Record Key93605023-f650-49f9-9a5c-2f8f6c64e399
Commercial Distribution StatusIn Commercial Distribution
Version Model Number111454
Catalog Number111454
Company DUNS045483575
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010038999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


[03596010038999]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-07
Device Publish Date2015-08-25

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00885556902035 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 40MM CORTEX SCREW BLUNT TIP

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