Total Foot System 2 2845116

GUDID 00885556839386

3.5MM PLATE COMPRESSION SCREW 16MM

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00885556839386
NIH Device Record Key2a9f2885-6721-4e18-9259-457283b3d1cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Foot System 2
Version Model Number2845116
Catalog Number2845116
Company DUNS045483575
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556839386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

[00885556839386]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-07
Device Publish Date2022-12-21

On-Brand Devices [Total Foot System 2]

00885556839935TX 8 DRIVER. NON-CANNULATED W/AO
00885556839881MODIFIED MINI JANSEN RETRACTORS
00885556839867MPJ 1.8MM INTERFRAG DRILL GUIDE RIGHT
00885556839850REARFOOT DISTRACTION GAUGE
00885556839843TFS PLATE BENDER HANDLE ASSY. SMALL
00885556839836TFS PLATE BENDER HANDLE ASSY. LARGE
00885556839829MPJ 1.8MM INTERFRAG DRILL GUIDE LEFT
008855568398122.5MM LOCKING DRILL GUIDE (YELLOW)
00885556839799K-WIRE DISTRACTION/COMPRESSION FORCEPS
008855568397822.5MM HEX DRIVER. NON-CANNULATED W/AO
00885556839775FOREFOOT DISTRACTION GAUGE
00885556837849DOUBLE DRILL GUIDE HANDLE
00885556828106PLATE BENDING IRON
00885556828069CUP & CONE CADDY LID
00885556828052CONE SPHERICAL REAMER SZ. 24MM
00885556828045CONE SPHERICAL REAMER SZ. 21MM
00885556828038CONE SPHERICAL REAMER SZ. 19MM
00885556828021CONE SPHERICAL REAMER SZ. 16MM
00885556828014CUP SPHERICAL REAMER SZ. 24MM
00885556828007CUP SPHERICAL REAMER SZ. 21MM
00885556827994CUP SPHERICAL REAMER SZ. 19MM
00885556827987CUP SPHERICAL REAMER SZ. 16MM
00885556838990OPEN WEDGE PLATE STEM SZ. 6MM
00885556838983OPEN WEDGE PLATE STEM SZ. 5MM
00885556838976OPEN WEDGE PLATE STEM SZ. 4MM
00885556838969OPEN WEDGE PLATE STEM SZ. 3MM
00885556838952OPEN WEDGE PLATE STEM SZ. 2MM
00885556838945OPEN WEDGE PLATE STEM SZ. 0MM
00885556838327TARSALIS PLATE 10 HOLE STRAIGHT
00885556838310TARSALIS PLATE 3 HOLE STRAIGHT LONG
00885556838297TARSALIS PLATE 2 HOLE STRAIGHT SHORT
00885556838259MPJ FUSION PLATE LONG RIGHT
00885556838228MPJ FUSION PLATE MEDIUM LEFT
00885556838211CALCANEUS PLATE SZ. MINI-LONG
00885556838303TARSALIS PLATE 2 HOLE STRAIGHT LONG
00885556838242MPJ FUSION PLATE LONG LEFT
00885556838235MPJ FUSION PLATE MEDIUM RIGHT
00885556838204CALCANEUS PLATE SZ. MINI
00885556837870OLIVE WIRE 1.1MM DIA. X 100MM
00885556837993FOREFOOT UNIVERSAL PLATE. 18MM
00885556837986FOREFOOT UNIVERSAL PLATE. 16MM
00885556837979FOREFOOT UNIVERSAL PLATE. 14MM
00885556839027OPEN WEDGE PLATE. 4.5MM
00885556839010OPEN WEDGE PLATE. 3.5MM
00885556839003OPEN WEDGE PLATE. 2.5MM
00885556838433TARSALIS PLATE. 8-HOLE T SHAPE RIGHT
00885556838426TARSALIS PLATE. 7-HOLE T SHAPE RIGHT
00885556838419TARSALIS PLATE. 6-HOLE T SHAPE STRAIGHT
00885556838396TARSALIS PLATE. 4-HOLE STRAIGHT
00885556838341TARSALIS PLATE. 4-HOLE T SHAPE STRAIGHT
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