Katalyst Biopolar Radial Head System 225918

GUDID 00885556827468

18MM RADIAL HEAD SIZING WAND

Smith & Nephew, Inc.

Elbow radius prosthesis
Primary Device ID00885556827468
NIH Device Record Keyf971cd30-8af7-44d1-aef0-bf23eba455e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameKatalyst Biopolar Radial Head System
Version Model Number225918
Catalog Number225918
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
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556827468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


[00885556827468]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2023-01-19

On-Brand Devices [Katalyst Biopolar Radial Head System]

00885556827505KATALYST NYLON DEMO HOLDER
00885556827406TRIAL - RADIAL HEAD: 24MM
00885556827390TRIAL - RADIAL HEAD: 21MM
00885556827383TRIAL - RADIAL HEAD: 18MM
00885556827376TRIAL. STEM / SHAFT - 7.5MM
00885556827369TRIAL. STEM / SHAFT - 6.5MM
00885556827277KATALYST STERILIZATION TRAY
00885556827352REPLACEMENT SET SCREW
008855568273457.5MM KATALYST STEM
008855568273386.5MM KATALYST STEM
0088555682732124MM KATALYST RADIAL HEAD
0088555682748224MM RADIAL HEAD SIZING WAND
0088555682747521MM RADIAL HEAD SIZING WAND
0088555682746818MM RADIAL HEAD SIZING WAND

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