OTHER EXTERNAL FIXATION 71050105

GUDID 03596010428981

HEIDELBERG 3.8MM DRILL SLEEVE

Smith & Nephew, Inc.

Orthopaedic implantation sleeve, reusable
Primary Device ID03596010428981
NIH Device Record Key647de133-4f95-4981-b8a9-4e1e4e5179e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTHER EXTERNAL FIXATION
Version Model Number71050105
Catalog Number71050105
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010428981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

[03596010428981]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-07
Device Publish Date2015-08-25

On-Brand Devices [OTHER EXTERNAL FIXATION]

00885556534038RAIL DISTRACTOR LOW PROFILE RIGHT
00885556288344HA PIN 4.5MM THREAD DIA X 45MM X 150MM
00885556288290HA PIN 4.5MM THREAD DIA X 35MM X 150MM
00885556288245HA PIN 4.5MM THREAD DIA X 25MM X 150MM
00885556288191HA PIN 4.5MM THREAD DIA X 15MM X 150MM
00885556119686INSTRUMENT CASE
00885556119464CENTERING SLEEVE 6MM
00885556119457RANCHO CUBE WITH POST 1 HOLE
00885556119440RANCHO CUBE WITH POST 2 HOLE
008855561193413.8MM STEPDRILL - SHORT
008855561193344.8MM DRILL - SHORT
008855561193272.7MM STEPDRILL - LONG
008855561193103.8MM STEPDRILL - LONG
008855561193034.8MM DRILL - LONG
00885556119297TISSUE PROTECTOR - SHORT INTERNAL DIAMETER 6MM
00885556119280TISSUE PROTECTOR - LONG INTERNAL DIAMETER 6MM
00885556119273DRILL TISSUE PROTECTOR - SHORT INTERNAL DIAMETER 4.8MM
00885556119266DRILL TISSUE PROTECTOR - LONG INTERNAL DIAMETER 4.8MM
00885556119259TROCAR SHORT
00885556119242TROCAR LONG
00885556119211DEPTH GAUGE SHORT
00885556119204DEPTH GAUGE LONG
00885556059890EXTERNAL FIXATION HALF PIN HA 5MM X 30MM
00885556059807EXTERNAL FIXATION HALF PIN HA 6MM X 30MM
00885556059609EXTERNAL FIXATION HALF PIN HA 5MM X 25MM
00885556059319EXTERNAL FIXATION HALF PIN HA 6MM X 25MM
00885556059272EXTERNAL FIXATION HALF PIN HA 5MM X 45MM
00885556059135EXTERNAL FIXATION HALF PIN HA 6MM X 20MM
00885556059067EXTERNAL FIXATION HALF PIN HA 5MM X 20MM
00885556058862EXTERNAL FIXATION HALF PIN HA 6MM X 50MM
00885556058824EXTERNAL FIXATION HALF PIN HA 5MM X 40MM
00885556058534EXTERNAL FIXATION HALF PIN HA 6MM X 40MM
00885556057940EXTERNAL FIXATION HALF PIN HA 6MM X 35MM
00885556057926EXTERNAL FIXATION HALF PIN HA 5MM X 35MM
008855560574141 HOLE 3 DEGREE RANCHO CUBE
00885556049839FOCAL DOME OSTEOTOMY GUIDE ASSEMBLY
008855560487194 HOLE CUBE W/THREADED END
0088555604857317 DEGREE WEDGE
00885556045725EXTRA LONG STEINMAN PIN 3.2MM X 450MM
00885556045602TRACTION PIN W/TROCAR POINT BOTH ENDS 5/64X9.0
00885556045015HEX FIX SWIVEL ADAPTER
00885556012338COMPASS KNEE KIT
20885556012264COMPASS KNEE ALIGNMENT GUIDE
008855560121615MM X 25MM ARROW HALF PIN - STAINLESS STEEL
008855560121164.8MM DRILL BIT
208855560120663.2MM X 86MM TROCAR PIN
008855560119972.8MM DRILL BIT
00885556011744DISC CLIPS
20885556011434COMPASS KNEE ALIGNMENT STAND
00885556011089LARGE-STANDARD COMPRESSION/DISTRACTION MODULE
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