R3

Primary DI
00885556675434
Brand
R3
Company
Smith & Nephew, Inc.
Model
E0015356-3
Catalog number
E0015356-3
Device description
R3 SCREW-IN TRIAL LINER 0¿2/50
Published
2017-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556675434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556675434008855566754348855566754340885556675434

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996074901SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095661SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095685SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
00885556321942REDAPTSmith & Nephew, Inc.JDI2016-02-24
00885556321393REDAPTSmith & Nephew, Inc.JDI2015-12-11
00885556321492REDAPTSmith & Nephew, Inc.JDI2015-12-11
00885556321591REDAPTSmith & Nephew, Inc.JDI2015-12-11
00885556321690REDAPTSmith & Nephew, Inc.JDI2015-12-11
00885556321744REDAPTSmith & Nephew, Inc.JDI2015-12-11
00885556321843REDAPTSmith & Nephew, Inc.JDI2015-12-11
07611996013788SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013795SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013849SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996014990BOFOR/EP-FIT PLUS/PROMOS/MPFSmith & Nephew, Inc.JDI2015-11-25
07611996045208MODULAR-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996065343SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996076394SL-PLUSSmith & Nephew, Inc.JDI2015-11-25