Rim-Fix AL3778

GUDID 05051693308176

Poly Liner 10° Hood 56 x 32mm (UHMWPE) Uncemented

IMPLANTS INTERNATIONAL LTD

Constrained polyethylene acetabular liner

• Primary Device ID: 05051693308176
• NIH Device Record Key: 174b818f-185a-4db8-b41b-16dde53c69a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rim-Fix
• Version Model Number: Poly Liner 10° Hood 56 x 32mm
• Catalog Number: AL3778
• Company DUNS: 346627222
• Company Name: IMPLANTS INTERNATIONAL LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +4401642769080
• Email: jack.tait@implantsinternationa
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com
• Phone: +4401642769080
• Email: jack.tait@implantsinternational.com

Device Dimensions

• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter
• Outer Diameter: 56 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature and Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051693308176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993713

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-31

On-Brand Devices [Rim-Fix]

• 05051693309814: ACETABULAR DUAL COATED CUP UNCEMENTED -66mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309807: ACETABULAR DUAL COATED CUP UNCEMENTED -64mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309791: ACETABULAR DUAL COATED CUP UNCEMENTED -62mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309784: ACETABULAR DUAL COATED CUP UNCEMENTED -60mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309777: ACETABULAR DUAL COATED CUP UNCEMENTED -58mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309760: ACETABULAR DUAL COATED CUP UNCEMENTED -56mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309753: ACETABULAR DUAL COATED CUP UNCEMENTED -54mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309746: ACETABULAR DUAL COATED CUP UNCEMENTED -52mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309739: ACETABULAR DUAL COATED CUP UNCEMENTED -50mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309722: ACETABULAR DUAL COATED CUP UNCEMENTED -48mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309715: ACETABULAR DUAL COATED CUP UNCEMENTED -46mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS
• 05051693309708: PLASMA COATED ACETABULAR CUP - 66mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309692: PLASMA COATED ACETABULAR CUP - 64mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309685: PLASMA COATED ACETABULAR CUP - 62mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309678: PLASMA COATED ACETABULAR CUP - 60mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309661: PLASMA COATED ACETABULAR CUP - 58mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309654: PLASMA COATED ACETABULAR CUP - 56mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309647: PLASMA COATED ACETABULAR CUP - 54mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309630: PLASMA COATED ACETABULAR CUP - 52mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309623: PLASMA COATED ACETABULAR CUP - 50mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309616: PLASMA COATED ACETABULAR CUP - 48mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309609: PLASMA COATED ACETABULAR CUP - 46mm ( CP. Ti. PLASMA COATED ) FOR UNCEMENTED APPLICATIONS
• 05051693309593: Poly Liner Neutral 66 x 32mm (UHMWPE) Uncemented
• 05051693309579: Poly Liner Neutral 64 x 32mm (UHMWPE) Uncemented
• 05051693309135: Poly Liner 10° Hood 66 x 32mm (UHMWPE) Uncemented
• 05051693309128: Poly Liner 10° Hood 64 x 32mm (UHMWPE) Uncemented
• 05051693309111: Poly Liner 10° Hood 66 x 28mm (UHMWPE) Uncemented
• 05051693309104: Poly Liner 10° Hood 64 x 28mm (UHMWPE) Uncemented
• 05051693309098: Poly Liner 10° Hood 66 x 36mm (UHMWPE) Uncemented
• 05051693309081: Poly Liner 10° Hood 64 x 36mm (UHMWPE) Uncemented
• 05051693309074: Poly Liner 10° Hood 62 x 36mm (UHMWPE) Uncemented
• 05051693309067: Poly Liner 10° Hood 60 x 36mm (UHMWPE) Uncemented
• 05051693309050: Poly Liner 10° Hood 58 x 36mm (UHMWPE) Uncemented
• 05051693309043: Poly Liner 10° Hood 56 x 36mm (UHMWPE) Uncemented
• 05051693309036: Poly Liner 10° Hood 54 x 36mm (UHMWPE) Uncemented
• 05051693309029: Poly Liner 10° Hood 52 x 36mm (UHMWPE) Uncemented
• 05051693309012: Poly Liner 10° Hood 50 x 36mm (UHMWPE) Uncemented
• 05051693308992: Poly Liner Neutral 66 x 36mm (UHMWPE) Uncemented
• 05051693308985: Poly Liner Neutral 64 x 36mm (UHMWPE) Uncemented
• 05051693308978: Poly Liner Neutral 62 x 36mm (UHMWPE) Uncemented
• 05051693308961: Poly Liner Neutral 60 x 36mm (UHMWPE) Uncemented
• 05051693308954: Poly Liner Neutral 58 x 36mm (UHMWPE) Uncemented
• 05051693308947: Poly Liner Neutral 56 x 36mm (UHMWPE) Uncemented
• 05051693308930: Poly Liner Neutral 54 x 36mm (UHMWPE) Uncemented
• 05051693308923: Poly Liner Neutral 52 x 36mm (UHMWPE) Uncemented
• 05051693308916: Poly Liner Neutral 50 x 36mm (UHMWPE) Uncemented
• 05051693308909: Poly Liner 10° Hood 46 x 32mm (UHMWPE) Uncemented
• 05051693308893: Poly Liner 10° Hood 46 x 28mm (UHMWPE) Uncemented
• 05051693308206: Poly Liner 10° Hood 62 x 32mm (UHMWPE) Uncemented
• 05051693308190: Poly Liner 10° Hood 60 x 32mm (UHMWPE) Uncemented