Total Wrist Fusion System 303403

GUDID 00885556840177

DOUBLE-ENDED GUIDE FOR 2.0MM CORTICAL DRILL BIT

Smith & Nephew, Inc.

Surgical drill guide, reusable
Primary Device ID00885556840177
NIH Device Record Key7590c020-b753-4813-8d2c-7d7a3534f746
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Wrist Fusion System
Version Model Number303403
Catalog Number303403
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556840177 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

[00885556840177]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-10
Device Publish Date2023-02-02

On-Brand Devices [Total Wrist Fusion System]

00885556840368INSTRUMENT CASE COMPLETE - EMEA
00885556840306INSTRUMENT CASE COMPLETE - US
00885556840269PLATE BENDER - 3.5MM HOLE
00885556840252PLATE BENDER - 2.7MM HOLE
008855568402452.0MM SELF-RETAINING HEX DRIVER
008855568402382.5MM SELF-RETAINING HEX DRIVER
00885556840221SELF-RETAINING TORX DRIVER
00885556840214DEPTH GAUGE
00885556840184DOUBLE-ENDED GUIDE FOR 2.5MM CORTICAL DRILL BIT
00885556840177DOUBLE-ENDED GUIDE FOR 2.0MM CORTICAL DRILL BIT
00885556840344INSTRUMENT CASE LID (US/EMEA)
00885556840320INSTRUMENT CASE TOP LEVEL (US/EMEA)
00885556840290SHORT BEND PLATE TRIAL (EMEA SETS ONLY)
00885556840283STANDARD BEND PLATE TRIAL (EMEA SETS ONLY)
00885556840276STRAIGHT PLATE TRIAL (EMEA SETS ONLY)
008855568405423.5MM CORTICAL SCREW 28MM LONG
008855568405353.5MM CORTICAL SCREW 26MM LONG
008855568405283.5MM CORTICAL SCREW 24MM LONG
008855568405113.5MM CORTICAL SCREW 22MM LONG
008855568405043.5MM CORTICAL SCREW 20MM LONG
008855568404983.5MM CORTICAL SCREW 18MM LONG
008855568404813.5MM CORTICAL SCREW 16MM LONG
008855568404743.5MM CORTICAL SCREW 14MM LONG
008855568404673.5MM CORTICAL SCREW 12MM LONG
008855568404502.7MM CORTICAL SCREW 24MM LONG
008855568404432.7MM CORTICAL SCREW 22MM LONG
008855568404362.7MM CORTICAL SCREW 20MM LONG
008855568404292.7MM CORTICAL SCREW 18MM LONG
008855568404122.7MM CORTICAL SCREW 16MM LONG
008855568404052.7MM CORTICAL SCREW 14MM LONG
008855568403992.7MM CORTICAL SCREW 12MM LONG
008855568403822.7MM CORTICAL SCREW 10MM LONG
00885556840375INSTRUMENT CASE BASE (EMEA)
00885556840351WRIST FUSION SCREW CADDY LID
00885556840337INSTRUMENT CASE IMPLANT CADDY (US)
00885556840313INSTRUMENT CASE BASE (US)
00885556840207THREADED SURFIX DRILL GUIDE FOR 2.7MM DRILL BIT
00885556840191THREADED SURFIX DRILL GUIDE FOR 2.0MM DRILL BIT
008855568401602.7MM DRILL BIT
008855568401532.5MM DRILL BIT
008855568401462.0MM DRILL BIT
008855568401393.5MM CORTICAL SCREW 28MM LONG
008855568401223.5MM CORTICAL SCREW 26MM LONG
008855568401153.5MM CORTICAL SCREW 24MM LONG
008855568401083.5MM CORTICAL SCREW 22MM LONG
008855568400923.5MM CORTICAL SCREW 20MM LONG
008855568400853.5MM CORTICAL SCREW 18MM LONG
008855568400783.5MM CORTICAL SCREW 16MM LONG
008855568400613.5MM CORTICAL SCREW 14MM LONG
008855568400543.5MM CORTICAL SCREW 12MM LONG
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