PyroCarbon Lunate LUN-710-05-WW

GUDID 00885556858769

LUNATE SZ. 05

Smith & Nephew, Inc.

Carpal lunate prosthesis
Primary Device ID00885556858769
NIH Device Record Keybd8a3eaa-f769-40c7-be92-6f4e8a9f7d70
Commercial Distribution StatusIn Commercial Distribution
Brand NamePyroCarbon Lunate
Version Model NumberLUN-710-05-WW
Catalog NumberLUN-710-05-WW
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
GS100885556858769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWNProsthesis, wrist, carpal lunate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-10

On-Brand Devices [PyroCarbon Lunate]

00885556858813LUNATE SIZING TEMPLATE SZ. 05
00885556858806LUNATE SIZING TEMPLATE SZ. 04
00885556858790LUNATE SIZING TEMPLATE SZ. 03
00885556858783LUNATE SIZING TEMPLATE SZ. 02
00885556858776LUNATE SIZING TEMPLATE SZ. 01
00885556858868LUNATE TRIAL SZ. 05
00885556858851LUNATE TRIAL SZ. 04
00885556858844LUNATE TRIAL SZ. 03
00885556858837LUNATE TRIAL SZ. 02
00885556858820LUNATE TRIAL SZ. 01
00885556858769LUNATE SZ. 05
00885556858752LUNATE SZ. 04
00885556858745LUNATE SZ. 03
00885556858738LUNATE SZ. 02
00885556858721LUNATE SZ. 01
00885556858714LUNATE CASE
00885556858707LUNATE LID

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.