110338

GUDID 03596010469601

HIBBS OSTEOTOME CVD 28.5MM

Smith & Nephew, Inc.

Orthopaedic osteotome
Primary Device ID03596010469601
NIH Device Record Key680f689c-eb01-4315-8780-9044c5ce1e47
Commercial Distribution StatusIn Commercial Distribution
Version Model Number110338
Catalog Number110338
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
GS103596010469601 [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

[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

Moist Heat or Steam Sterilization


[03596010469601]

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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