R3 E0017369-3

GUDID 00885556806685

MIS ACETABULAR REAMER 50MM

Smith & Nephew, Inc.

Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable
Primary Device ID00885556806685
NIH Device Record Keyde7a5f1f-786b-49c9-8182-2c8ca10d6017
Commercial Distribution StatusIn Commercial Distribution
Brand NameR3
Version Model NumberE0017369-3
Catalog NumberE0017369-3
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556806685 [Primary]

FDA Product Code

HTOREAMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


[00885556806685]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [R3]

00885556741313NARROW BENT HOHMAN RETRACTOR
00885556741306DA COBRA RETRACTOR
00885556740705CUP ALIGNMENT HANDLE
00885556740699CUP IMPACTOR ADAPTER
00885556739280R3 SCREW-IN TRIAL LINER 0¿8/60
00885556738597SWIVEL CUP INSERTER
00885556736302ALIGNMENT GUIDE
00885556736296R3 CUP IMPACTOR
00885556736289R3 SCREW-IN TRIAL LINER 0 DEGREE 40/56
00885556736272R3 SCREW-IN TRIAL LINER 20 DEGREE 36/52
00885556732908SUPERPATH RETRACTOR
00885556732892U-RETRACTOR
00885556732670R3 SCREW-IN TRIAL LINER 20¿6/56
00885556732663R3 SCREW-IN TRIAL LINER 20¿6/54
00885556732656R3 SCREW-IN TRIAL LINER 20¿6/52
00885556732649R3 SCREW-IN TRIAL LINER 20¿2/50
00885556732632R3 SCREW-IN TRIAL LINER 20¿2/48
00885556732625R3 SCREW-IN TRIAL LINER 0¿6/56
00885556732618R3 SCREW-IN TRIAL LINER 0¿6/54
00885556732601R3 SCREW-IN TRIAL LINER 0¿6/52
00885556732595R3 SCREW-IN TRIAL LINER 0¿2/50
00885556732588R3 SCREW-IN TRIAL LINER 0¿2/48
00885556732564R3 CUP IMPACTOR
00885556732557MODIFIED R3 INSERTER
00885556732540R3 ANTI-ROTATION TIP W/FLAT SZ66/68MM
00885556732533R3 ANTI-ROTATION TIP W/FLAT SZ64MM
00885556732526R3 ANTI-ROTATION TIP W/FLAT SZ62MM
00885556732519R3 ANTI-ROTATION TIP W/FLAT SZ60MM
00885556732502R3 ANTI-ROTATION TIP W/FLAT SZ58MM
00885556732496R3 ANTI-ROTATION TIP W/FLAT SZ56MM
00885556732472R3 ANTI-ROTATION TIP W/FLAT SZ54MM
00885556732465R3 ANTI-ROTATION TIP W/FLAT SZ52MM
00885556732458R3 ANTI-ROTATION TIP W/FLAT SZ50MM
00885556732441R3 ANTI-ROTATION TIP W/FLAT SZ48MM
00885556732434R3 ANTI-ROTATION TIP W/FLAT SZ46MM
00885556732144CANNULA
00885556732137CUP IMPACTOR TIP
00885556732120LINER IMPACTOR - 40MM
00885556732113LINER IMPACTOR - 36MM
00885556732106LINER IMPACTOR - 32MM
00885556732090LINER IMPACTOR - 28MM
00885556732083REAMER CONNECTOR
00885556732076INSERTER TOOL
00885556732069LINER IMPACTOR FORCEPS
00885556732052IMPACTOR HANDLE
00885556732045REAMER HANDLE
00885556732038TROCAR
00885556732021HANDS FREE RETRACTOR - RIGHT
00885556732014HANDS FREE RETRACTOR - LEFT
00885556732007LARGE ANTERIOR RETRACTOR

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