SYNOVO HIP COMPONENTS 01-17-2846

GUDID 00814193026040

HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 46 MM O.D

Synovo Production

Bipolar humeral head outer component

• Primary Device ID: 00814193026040
• NIH Device Record Key: 229ae350-a4f1-4d8a-9fe6-0834a253a414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNOVO HIP COMPONENTS
• Version Model Number: 01-17-2846
• Catalog Number: 01-17-2846
• 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

• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 46 Millimeter
• Lumen/Inner Diameter: 28 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814193026040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884889

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

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: 2024-03-22
• Device Publish Date: 2024-03-14

On-Brand Devices [SYNOVO HIP COMPONENTS]

• 00814193026163: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 58 MM O.D.
• 00814193026156: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 57 MM O.D.
• 00814193026149: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 56 MM O.D.
• 00814193026132: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 55 MM O.D.
• 00814193026125: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 54 MM O.D.
• 00814193026118: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 53 MM O.D
• 00814193026101: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 51 MM O.D.
• 00814193026095: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 52 MM O.D.
• 00814193026088: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 50 MM O.D.
• 00814193026071: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 49 MM O.D.
• 00814193026064: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 48 MM O.D.
• 00814193026057: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 47 MM O.D.
• 00814193026040: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 46 MM O.D
• 00814193026033: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 45 MM O.D.
• 00814193026026: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 44 MM O.D.
• 00814193026019: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 43 MM O.D.
• 00814193026002: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 41 MM O.D.
• 00814193025999: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 42 MM O.D.
• 00814193025982: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 40 MM O.D.
• 00814193025975: HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 39 MM O.D.