FDA.reportPublic FDA data

Journey II

Primary DI
00885556867907
Brand
Journey II
Company
Smith & Nephew, Inc.
Model
E0017558-1
Catalog number
E0017558-1
Device description
JII PATELLA PROTECTOR ROUND PEGGED 26MM
Published
2021-12-13
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556867907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556867907008855568679078855568679070885556867907

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811767027779FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027786FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027793FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027809FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
08033390281751PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281775PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281782PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281799PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281904PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281911PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281928PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281935PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281942PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281959PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281966PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281973PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281980PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281997PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282000PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282024PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282048PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282055PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282062PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282079PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
04026575448630LinkSymphoKneeWALDEMAR LINK GmbH & Co. KGHRY2025-04-02
04026575448647LinkSymphoKneeWALDEMAR LINK GmbH & Co. KGHRY2025-04-02
00885556921388LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921395LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921401LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921418LegionSmith & Nephew, Inc.HRY2024-11-26