FDA.reportPublic FDA data

R3

Primary DI
00885556653418
Brand
R3
Company
Smith & Nephew, Inc.
Model
E0015118-7
Catalog number
E0015118-7
Device description
MODIFIED +4MM OFFSET TRIAL HEAD SZ36MM
Published
2016-07-19
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
LPOGASES USED WITHIN EYE TO PLACE PRESSURE ON DETACHED RETINA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPOGases Used Within Eye To Place Pressure On Detached RetinaOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132435000SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALSSmith & Nephew, Inc.2013-10-22LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556653418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556653418008855566534188855566534180885556653418

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
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
20885556628908NavioPFSDV0016PFSDV00162016-09-21
00885556820964General InstrumentsMA3511NDMA3511ND2023-10-27
00885556822722Capture High Torque Screw SystemMAT-000-02MAT-000-022022-12-21
00885556822937Total Foot System 23210103210102022-12-21
00885556822944Total Foot System 23210123210122022-12-21
00885556828090XT Revision Ankle Replacement SystemMJV551TMJV551T2022-12-21
00885556832431Salto Talaris Total Ankle ProsthesisMJU012TMJU012T2022-12-21
00885556837825Total Foot System 23820003820002022-12-22
00885556840375Total Wrist Fusion System3035113035112022-12-21
00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
00885556855003Freedom Wrist Arthroplasty System3480593480592022-12-22
00885556858301PyroCarbon PIP Total Joint SystemOSG-200-00OSG-200-002022-12-22
00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
00885556858363PyroCarbon PIP Total Joint SystemOSG-200-30PVOSG-200-30PV2022-12-22
00885556858387PyroCarbon PIP Total Joint SystemOSG-200-40PVOSG-200-40PV2022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819601025660BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025677BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025684BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025691BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025707BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00819601025714BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025667BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025674BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025681BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025698BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025704BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
10819601025711BVI Medical Airgas Therapeutics, LLCLPO2025-05-20
00380657530663UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
00380657530670UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
00380657530687UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
00380657530694UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
10380657530660UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
10380657530677UNIPURE & UNIFEYEAlcon Laboratories, Inc.LPO2024-10-28
10380657530684UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
10380657530691UNIPURE & UNIPEXYAlcon Laboratories, Inc.LPO2024-10-28
00885556653371R3Smith & Nephew, Inc.LPO2016-07-19
00885556653388R3Smith & Nephew, Inc.LPO2016-07-19
00885556653395R3Smith & Nephew, Inc.LPO2016-07-19
00885556653401R3Smith & Nephew, Inc.LPO2016-07-19
00885556653425R3Smith & Nephew, Inc.LPO2016-07-19
10860113000109ISPAN C3F8 Intraocular GasESCALON MEDICAL CORP.LPO2014-11-05
10860113000116ISPAN SF6 Intraocular GasESCALON MEDICAL CORP.LPO2014-11-05
00380657971046ISPANAlcon Laboratories, Inc.LPO2014-10-07
00380657970018ISPANAlcon Laboratories, Inc.LPO2014-09-24
00380657970025ISPANAlcon Laboratories, Inc.LPO2014-09-24