Genesis II E0017159-14

GUDID 00885556797006

O-RING CEMENT CLAMP

Smith & Nephew, Inc.

Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp
Primary Device ID00885556797006
NIH Device Record Key65a40138-6c7d-42ab-92f7-555991d98f67
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesis II
Version Model NumberE0017159-14
Catalog NumberE0017159-14
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556797006 [Primary]
GS100885556797006 [Primary]
GS100885556797006 [Primary]
GS100885556797006 [Primary]
GS100885556797006 [Primary]
GS100885556797006 [Primary]
GS100885556797006 [Primary]
GS100885556797006 [Primary]

FDA Product Code

HXDCLAMP
HXDCLAMP
HXDCLAMP
HXDCLAMP
HXDCLAMP
HXDCLAMP
HXDCLAMP
HXDCLAMP

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


[00885556797006]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Genesis II]

00885556728857P/S REAMING COLLET SZ 4
00885556728840CHISEL SPACER H-BLOCK
00885556727256ALIGNMENT PLATE LONG & WIDE ARMS
00885556727249GENESIS II TIBIAL TRAY IMPLANT IMPACTOR W ALIGNMENT
00885556727225STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 8 RT
00885556727218STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 7 RT
00885556727201STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 6 RT
00885556727195STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 5 RT
00885556727188STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 4 RT
00885556727171STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 3 RT
00885556727164STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 2 RT
00885556727157STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 8 LT
00885556727140STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 7 LT
00885556727133STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 6 LT
00885556727126STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 5 LT
00885556727119STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 4 LT
00885556727102STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 3 LT
00885556727096STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 2 LT
00885556726723STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 5 RT
00885556726716STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 4 RT
00885556726488THINNED SPACER BLOCK
00885556675250GII REAM THROUGH FEMORAL TRIAL SZ5 LEFT
00885556671306LONGER SPIKED DCF VALGUS ALIGNMENT GUIDE
0088555665141432MM ROUND PATELLA PROTECTOR W/ SPIKES
0088555665131529MM GII PATELLA PROTECTOR W/ PEGS
0088555665130826MM GII PATELLA PROTECTOR WITH PEGS
0088555665029510MM X 70MM STEM TRIAL
0088555665028814MM REAMER WITH A POSITIVE STOP FOR 10MM X 70MM STEM
00885556648568Tibia Trial with Anterior Pin Holes Sz 1 Left
00885556648551TIBIA TRIAL WITH ANTERIOR PIN HOLES SZ 1 RIGHT
0088555664797435MM OVAL PATELLA PROTECTOR GENESIS II
0088555664796729 MM OVAL PATELLAR PROTECTOR GENESIS II
00885556647875SIZE 8 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
00885556647868SIZE 7 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
00885556647851SIZE 6 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
00885556647844SIZE 5 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
00885556647837SIZE 4 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
00885556647820SIZE 3 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
00885556645680FEMORAL DOWNSIZING DRILL GUIDE WITH 1 &3 MM HOLES ADDED
00885556635247CRUCIATE RETAINING DISHED TRIAL INSERT 7-8 11MM
00885556635230CRUCIATE RETAINING DISHED TRIAL INSERT 5-6 11MM
00885556635223CRUCIATE RETAINING DISHED TRIAL INSERT 3-4 11MM
00885556635216CRUCIATE RETAINING DISHED TRIAL INSERT 1-2 11MM
00885556635209CRUCIATE RETAINING DISHED TRIAL INSERT 7-8 9MM
00885556635193CRUCIATE RETAINING DISHED TRIAL INSERT 5-6 9MM
00885556635186CRUCIATE RETAINING DISHED TRIAL INSERT 3-4 9MM
00885556635179CRUCIATE RETAINING DISHED TRIAL INSERT 1-2 9MM
00885556635162CONSTRAINED TRIAL INSERT 7-8 11MM
00885556635155CONSTRAINED TRIAL INSERT 5-6 11MM
00885556635148CONSTRAINED TRIAL INSERT 3-4 11MM

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