111465

GUDID 00885556007044

HOKE OSTEOTOME 3.8 X 6

Smith & Nephew, Inc.

Orthopaedic osteotome
Primary Device ID00885556007044
NIH Device Record Key4d51bbe2-8188-42d4-8858-b11899f6d827
Commercial Distribution StatusIn Commercial Distribution
Version Model Number111465
Catalog Number111465
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556007044 [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

[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


[00885556007044]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-25

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00885556902011 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 36MM CORTEX SCREW BLUNT TIP
00885556902028 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 38MM CORTEX SCREW BLUNT TIP
00885556902035 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 40MM CORTEX SCREW BLUNT TIP

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