110107

GUDID 23596010033912

SET SCREWS FOR RICHARDS COLLES FRACTURE FRAME

Smith & Nephew, Inc.

External orthopaedic fixation system, reusable
Primary Device ID23596010033912
NIH Device Record Keyadc0eb2d-ebcb-4d57-b814-cb589846fb02
Commercial Distribution StatusIn Commercial Distribution
Version Model Number110107
Catalog Number110107
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 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
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
GS103596010033918 [Primary]
GS123596010033912 [Package]
Contains: 03596010033918
Package: BX [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


[23596010033912]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-11-03
Device Publish Date2015-08-29

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.