71161065

GUDID 03596010301840

TITANIUM CANNULATED SCREW 6.5MM X 65MM

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID03596010301840
NIH Device Record Key6ffab4ad-f557-4688-8fb8-972cd9043b73
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71161065
Catalog Number71161065
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exempttrue
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 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
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
GS103596010301840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


[03596010301840]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-22
Device Publish Date2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

00885556897102 - INTERTAN MAX2025-11-19 INTERTAN MAX 10MM X 24CM X 125D LEFT
00885556897119 - INTERTAN MAX2025-11-19 INTERTAN MAX 10MM X 24CM X 125D RIGHT
00885556897126 - INTERTAN MAX2025-11-19 INTERTAN MAX 11.5MM X 24CM X 125D LEFT
00885556897133 - INTERTAN MAX2025-11-19 INTERTAN MAX 11.5MM X 24CM X 125D RIGHT
00885556897201 - INTERTAN MAX2025-11-19 INTERTAN MAX 9MM X 38CM X 125D LEFT
00885556897218 - INTERTAN MAX2025-11-19 INTERTAN MAX 9MM X 40CM X 125D LEFT
00885556897225 - INTERTAN MAX2025-11-19 INTERTAN MAX 9MM X 42CM X 125D LEFT
00885556897232 - INTERTAN MAX2025-11-19 INTERTAN MAX 9MM X 44CM X 125D LEFT

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.