FDA.reportPublic FDA data

R3

Primary DI
03596010607010
Brand
R3
Company
Smith & Nephew, Inc.
Model
71369894
Catalog number
71369894
Device description
R3 SCREW HOLE COVER
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070756000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070756000SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEMSmith & Nephew, Inc.2007-06-06MBL
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010607010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010607010035960106070103596010607010

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis hole plugA sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00: -

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30
00885556236949STRUCSURE7178057178052016-04-08
00885556236994STRUCSURE7178087178082016-04-08
00885556237045STRUCSURE7178167178162016-04-08
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327208832INSTRUMENTHowmedica Osteonics Corp.MBL2016-09-24
04546540273260OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273291OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273314OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273345OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273369OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273390OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402158OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402165OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402172OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402189OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540432001TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153071273RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.MBL2015-09-24