SYNOVO HIP SYSTEM 01-01-0558

GUDID 00814193025821

HIP ACETABULAR FIXATION CUP - 58 MM 5 HOLE

Synovo Production

Ceramic-on-polyethylene total hip prosthesis

• Primary Device ID: 00814193025821
• NIH Device Record Key: 4cdf5cb4-9221-498f-912d-f1d5f0154b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNOVO HIP SYSTEM
• Version Model Number: 01-01-0558
• Catalog Number: 01-01-0558
• Company DUNS: 061486164
• Company Name: Synovo Production
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 58 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814193025821 [Primary]

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [SYNOVO HIP SYSTEM]

• 00814193025753: HIP FEMORAL RESURFACING CUP -52.5 MM
• 00814193025746: HIP FEMORAL RESURFACING CUP - 36.5 MM
• 00814193025739: HIP FEMORAL RESURFACING CUP - 38MM
• 00814193025722: HIP FEMORAL RESURFACING CUP 39.5MM
• 00814193025715: HIP FEMORAL RESURFACING CUP 41MM
• 00814193025708: HIP FEMORAL RESURFACING CUP - 42.5MM
• 00814193025692: HIP FEMORAL RESURFACING CUP - 45.5 MM
• 00814193025685: HIP FEMORAL RESURFACING CUP - 47 MM
• 00814193025678: HIP FEMORAL RESURFACING CUP - 44MM
• 00814193025661: HIP FEMORAL RESURFACING CUP - 51MM
• 00814193025654: HIP FEMORAL RESURFACING CUP - 49MM
• 00814193025968: HIP ACETABULAR BEARING - 49 MM I.D. X 62 MM O.D.
• 00814193025951: HIP ACETABULAR BEARING - 52.5 MM I.D. X 66 TO 70 MM O.D.
• 00814193025944: HIP ACETABULAR BEARING - 51 MM I.D. X 64 MM O.D.
• 00814193025937: HIP ACETABULAR BEARING - 47 MM I.D. X 60 MM O.D.
• 00814193025920: HIP ACETABULAR BEARING - 45.5 MM I.D. X 58 MM O.D.
• 00814193025913: HIP ACETABULAR BEARING - 44 MM I.D. X 56 MM O.D.
• 00814193025906: HIP ACETABULAR BEARING - 42.5 MM I.D. X 54 MM O.D.
• 00814193025890: HIP ACETABULAR BEARING - 41 MM I.D. X 52 MM O.D.
• 00814193025883: HIP ACETABULAR FIXATION CUP - 70 MM 5 HOLE
• 00814193025876: HIP ACETABULAR FIXATION CUP - 68 MM 5 HOLE
• 00814193025869: HIP ACETABULAR FIXATION CUP - 66 MM 5 HOLE
• 00814193025852: HIP ACETABULAR FIXATION CUP - 64 MM 5 HOLE
• 00814193025845: HIP ACETABULAR FIXATION CUP - 62 MM 5 HOLE
• 00814193025838: HIP ACETABULAR FIXATION CUP - 60 MM 5 HOLE
• 00814193025821: HIP ACETABULAR FIXATION CUP - 58 MM 5 HOLE
• 00814193025814: HIP ACETABULAR FIXATION CUP - 56 MM 5 HOLE
• 00814193025807: HIP ACETABULAR FIXATION CUP - 54 MM 5 HOLE
• 00814193025791: HIP ACETABULAR FIXATION CUP - 52 MM 5 HOLE
• 00814193025784: HIP ACETABULAR FIXATION CUP - 50 MM 5 HOLE
• 00814193025777: HIP ACETABULAR FIXATION CUP - 48 MM 5 HOLE
• 00814193025760: HIP ACETABULAR FIXATION CUP - 46 MM 5 HOLE