FDA.reportPublic FDA data

SYNOVO HIP COMPONENTS

Primary DI
00814193025937
Brand
SYNOVO HIP COMPONENTS
Company
Synovo Production
Model
01-02-4760
Catalog number
01-02-4760
Device description
HIP ACETABULAR BEARING - 47 MM I.D. X 60 MM O.D.
Published
2024-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193025937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193025937008141930259378141930259370814193025937

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic-on-polyethylene total hip prosthesisA sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter47Millimeter
Outer Diameter60Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061486164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814193025975SYNOVO HIP COMPONENTS01-17-283901-17-28392024-03-14
00814193025982SYNOVO HIP COMPONENTS01-17-284001-17-28402024-03-14
00814193025999SYNOVO HIP COMPONENTS01-17-284201-17-28422024-03-14
00814193026002SYNOVO HIP COMPONENTS01-17-284101-17-28412024-03-14
00814193026019SYNOVO HIP COMPONENTS01-17-284301-17-28432024-03-14
00814193026026SYNOVO HIP COMPONENTS01-17-284401-17-28442024-03-14
00814193026033SYNOVO HIP COMPONENTS01-17-284501-17-28452024-03-14
00814193026040SYNOVO HIP COMPONENTS01-17-284601-17-28462024-03-14
00814193026057SYNOVO HIP COMPONENTS01-17-284701-17-28472024-03-14
00814193026064SYNOVO HIP COMPONENTS01-17-284801-17-28482024-03-14
00814193026071SYNOVO HIP COMPONENTS01-17-284901-17-28492024-03-14
00814193026088SYNOVO HIP COMPONENTS01-17-285001-17-28502024-03-14
00814193026095SYNOVO HIP COMPONENTS01-17-285201-17-28522024-03-14
00814193026101SYNOVO HIP COMPONENTS01-17-285101-17-28512024-03-14
00814193026118SYNOVO HIP COMPONENTS01-17-285301-17-28532024-03-14
00814193026125SYNOVO HIP COMPONENTS01-17-285401-17-28542024-03-14
00814193026132SYNOVO HIP COMPONENTS01-17-285501-17-28552024-03-14
00814193026149SYNOVO HIP COMPONENTS01-17-285601-17-28562024-03-14
00814193026156SYNOVO HIP COMPONENTS01-17-285701-17-28572024-03-14
00814193026163SYNOVO HIP COMPONENTS01-17-285801-17-28582024-03-14

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