7205798

GUDID 03596010441539

FOOT PEDAL ACCESS 15 PUMP

Smith & Nephew, Inc.

Foot-switch, electrical
Primary Device ID03596010441539
NIH Device Record Key15cecd81-ba09-4ae5-9c12-150015c7b1dc
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7205798
Catalog Number7205798
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)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010441539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-23

Devices Manufactured by Smith & Nephew, Inc.

00885556894279 - NA2025-05-23 TRIGEN MAX 0MM NAIL CAP
00885556894286 - NA2025-05-23 TRIGEN MAX 5MM NAIL CAP
00885556894293 - NA2025-05-23 TRIGEN MAX 10MM NAIL CAP
00885556894309 - NA2025-05-23 TRIGEN MAX 15MM NAIL CAP
00885556894316 - NA2025-05-23 TRIGEN MAX 20MM NAIL CAP
00885556895528 - TRIGEN MAX2025-05-22 TRIGEN MAX COMPRESSION SET SCREW (3.5MM HEX)
00885556892954 - TRIGEN MAX2025-05-20 TRIGEN MAX TIBIA NAIL 9MM X 29CM LEFT
00885556894552 - NA2025-05-20 TRIGEN MAX 5.0MM LOCKING SCREW - 77.5MM

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