7203590

GUDID 03596010248756

REPL SEALS PS3500 BLADE

Smith & Nephew, Inc.

Surgical instrument seal/seal maintenance set
Primary Device ID03596010248756
NIH Device Record Key417640db-4919-4abf-93df-751c82b9ba2c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7203590
Catalog Number7203590
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
GS103596010248756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIJINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-31
Device Publish Date2015-09-21

Devices Manufactured by Smith & Nephew, Inc.

00885556900284 - TRIGEN MAX2025-06-10 TRIGEN MAX 13MM WASHER
00885556901960 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP
00885556901977 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 28MM CORTEX SCREW BLUNT TIP
00885556901984 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP
00885556901991 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 32MM CORTEX SCREW BLUNT TIP
00885556902004 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 34MM CORTEX SCREW BLUNT TIP
00885556902011 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 36MM CORTEX SCREW BLUNT TIP
00885556902028 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 38MM CORTEX SCREW BLUNT TIP

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