GUHL/ACUFEX 6905009

GUDID 00885554008258

MTO BAR SUPPORT GUHL ANKLE DISTRACTOR

Smith & Nephew, Inc.

Leg procedure positioner
Primary Device ID00885554008258
NIH Device Record Key7a6c27a2-b23e-4c81-b63e-76e4499273c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGUHL/ACUFEX
Version Model Number6905009
Catalog Number6905009
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885554008258 [Primary]

FDA Product Code

KQZCOMPONENT, TRACTION, NON-INVASIVE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


[00885554008258]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2016-04-12

Devices Manufactured by Smith & Nephew, Inc.

00885556915875 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 4KO VIDIOARTHROSCOPE AC 4 X 30 DEG X 160MM REVERSE POST
00885556915882 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
00885556915899 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
00885556915905 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
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

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