CHS 71115045

GUDID 03596010173607

QUICK CONNECT T-HANDLE

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting
Primary Device ID03596010173607
NIH Device Record Key13da2bad-9be7-4c60-904f-0312e6c75b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHS
Version Model Number71115045
Catalog Number71115045
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
GS103596010173607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


[03596010173607]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-07
Device Publish Date2015-08-25

On-Brand Devices [CHS]

00885556158241130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 25M
00885556158234130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 30M
00885556158227130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 35M
00885556158210130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 40M
00885556158203130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 45M
00885556158197130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 50M
00885556158180130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 55M
00885556158173130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 25MM
00885556158166130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 4HOLE 25MM
00885556158159130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 30MM
00885556158142130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 4HOLE 30MM
00885556158135130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 35MM
00885556158128130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 4HOLE 35MM
00885556158111130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 40MM
00885556158104130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 45MM
00885556158098130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 50MM
00885556158081130 DEGREE CHILD CANNULATED BLADE PLATE NO OFFSET 3HOLE 55MM
00885556158074130 DEGREE INFANT CANNULATED BLADE PLATE NO OFFSET 3HOLE 20M
00885556118078AMBI/CL SCREW CADDY LID
00885556077238CANN HIP PIN GUIDE WIRE 2.4X450MM W/230MM MARKINGS
00885556076569GUIDE PIN 230MM X 2.4MM
20885556076327GUIDE PIN 230MM X2.4MM STERILE PACK IN 6 EACH
00885556076064GUIDE PIN 2.4MM X 305MM
00885556060254PEDI CHS PLATE 100 DEG PROX SLOT 1 HOLE
00885556055885INTERMEDIATE PLATE 90DEG 3H W/4MM OFF
00885556049655CANN BLADE PLATE 3 HL 55MM ADOL 90DEG
00885556045091PED NON-THREADED TIP CALIBRATED GD PIN 1.6MM STER
00885556044247CAL GDE PIN 2.4 PED NONTHRD 6 PK
00885556043899INTERMED NON-THRD TIP CALIBRATED GD PIN 2.4MM STER
00885556043325CANNULATED OSTEOTOMY BLADE PLATE 35MM INFANT
00885556043240CANNULATED OSTEO BLADE PLATE 4 HOLE ADOLS 60MM
00885556043172120 DEGREE 4 HOLE 30MM CHILD CANN OSTEO BL PL
00885556043028120 DEGREE 3 HOLE 35MM CHILD CANN OSTEO BL PL
00885556042809120 DEGREE 4 HOLE 35MM CHILD CANN OSTEO BL PL
00885556042779CANN OSTEO BLADE PLATE 3 HL ADOL 60MM LENGTH
00885556042731120 DEGREE 3 HOLE 30MM CHILD CANN OSTEO BL PL
00885556042632CANN OSTEO BLADE PLATE 4 HOLE ADOL 55MM LENGTH
00885556042557120 DEGREE 3 HOLE 30MM INFANT CANN OSTEO BL PL
00885556042335120 DEGREE 3 HOLE 25MM INFANT CANN OSTEO BL PL
00885556042328CANNULATED OSTEOTOMY BLADE PLATE 40MM INFANT
00885556017784INTERTAN CHS BARREL REAMER
00885556017692INTERTAN CHS PLATE RETAINING ROD
00885556017470INTERTAN CHS COMPRESSION SCREW DRIVER
00885556017456BARREL REAMER SLEEVE
00885556017418INTERTAN CHS ALIGNMENT TROCAR
00885556017364INTERTAN CHS IMPLANT TRAY
00885556017357INTERTAN CHS ANTI ROTATION BAR
00885556017319INTERTAN CHS BARREL REAMER SLEEVE
00885556017234INTERTAN CHS PLATE INSERTION HANDLE
00885556017227BARREL REAMER

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.