R3 ACETABULAR 71369775

GUDID 20885556028500

R3 36MM CERAMIC DISPOSABLE TRIAL LINER 58MM OD

Smith & Nephew, Inc.

Acetabulum prosthesis trial, reusable
Primary Device ID20885556028500
NIH Device Record Keyfbdada69-a5e2-425a-b62c-1842f2d3b79c
Commercial Distribution StatusIn Commercial Distribution
Brand NameR3 ACETABULAR
Version Model Number71369775
Catalog Number71369775
Company DUNS109903521
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone1-800-238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556028506 [Primary]
GS120885556028500 [Package]
Contains: 00885556028506
Package: BX [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2015-05-06

On-Brand Devices [R3 ACETABULAR]

00885556281444R3 32MM ID US CERAMIC FORTE ACET LINER 58MM
00885556281390R3 32MM ID US CERAMIC FORTE ACET LINER 56MM
00885556274965R3 32MM ID US CERAMIC FORTE ACET LINER 54MM
00885556274910R3 32MM ID US CERAMIC FORTE ACET LINER 52MM
00885556274866R3 28MM ID US CERAMIC FORTE ACET LINER 50MM
00885556274415R3 28MM ID US CERAMIC FORTE ACET LINER 48MM
20885556028692R3 36MM CERAMIC DISPOSABLE TRIAL LINER 60MM OD
20885556028500R3 36MM CERAMIC DISPOSABLE TRIAL LINER 58MM OD
20885556028296R3 36MM CERAMIC DISPOSABLE TRIAL LINER 56MM OD
20885556027879R3 32MM CERAMIC DISPOSABLE TRIAL LINER 50MM OD
20885556027732R3 32MM CERAMIC DISPOSABLE TRIAL LINER 48MM OD
00885556027646R3 36MM CERAMIC DISPOSABLE TRIAL LINER 54MM OD
20885556027381R3 36MM CERAMIC DISPOSABLE TRIAL LINER 64MM OD
20885556027251R3 36MM CERAMIC DISPOSABLE TRIAL LINER 52MM OD
20885556026988R3 36MM CERAMIC DISPOSABLE TRIAL LINER 62MM OD
00885556022894R3 36MM ID US CERAMIC ACET LINER MM58
00885556022313R3 36MM ID US CERAMIC ACET LINER MM66/68
00885556022115R3 36MM ID US CERAMIC ACET LINER MM56
00885556022047R3 32MM ID US CERAMIC ACET LINER MM48
00885556021927R3 36MM ID US CERAMIC ACET LINER MM54
00885556021750R3 36MM ID US CERAMIC ACET LINER MM64
00885556021552R3 36MM ID US CERAMIC ACET LINER 52MM
00885556021309R3 36MM ID US CERAMIC ACET LINER MM62
00885556020685R3 36MM ID US CERAMIC ACET LINER MM60
00885556020661R3 32MM ID US CERAMIC ACET LINER MM50
03596010600707R3 36MM ID CERAMIC ACET TRL LNR 64MM
03596010600691R3 36MM ID CERAMIC ACET TRL LNR 62MM
03596010600646R3 36MM ID CERAMIC ACET TRL LNR 52MM
03596010600622R3 32MM ID CERAMIC ACET TRL LNR 48MM
03596010598325R3 3 HOLE ACETABULAR SHELL 68MM
03596010598318R3 3 HOLE ACETABULAR SHELL 66MM
03596010598301R3 3 HOLE ACETABULAR SHELL 64MM
03596010598295R3 3 HOLE ACETABULAR SHELL 62MM
03596010598288R3 3 HOLE ACETABULAR SHELL 60MM
03596010598271R3 3 HOLE ACETABULAR SHELL 58MM
03596010598264R3 3 HOLE ACETABULAR SHELL 56MM
03596010598257R3 3 HOLE ACETABULAR SHELL 54MM
03596010598240R3 3 HOLE ACETABULAR SHELL 52MM
03596010598233R3 3 HOLE ACETABULAR SHELL 50MM
03596010598226R3 3 HOLE ACETABULAR SHELL 48MM
03596010597670R3 0 HOLE ACETABULAR SHELL 68MM
03596010597656R3 0 HOLE ACETABULAR SHELL 64MM
03596010597649R3 0 HOLE ACETABULAR SHELL 62MM
03596010597632R3 0 HOLE ACETABULAR SHELL 60MM
03596010597625R3 0 HOLE ACETABULAR SHELL 58MM
03596010597618R3 0 HOLE ACETABULAR SHELL 56MM
03596010597601R3 0 HOLE ACETABULAR SHELL 54MM
03596010597595R3 0 HOLE ACETABULAR SHELL 52MM
03596010597588R3 0 HOLE ACETABULAR SHELL 50MM
03596010597571R3 0 HOLE ACETABULAR SHELL 48MM

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