Cermet Series III AS4125

GUDID 05051693310773

Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 64mm (Dia)

IMPLANTS INTERNATIONAL LTD

Acetabular shell

• Primary Device ID: 05051693310773
• NIH Device Record Key: 5b9e5a20-a6e2-4836-833d-28a112b2acb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cermet Series III
• Version Model Number: Bi-Coated Acetabular Cup 64mm
• Catalog Number: AS4125
• 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: michael.russon@implantsinterna
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com
• Phone: +4401642769080
• Email: michael.russon@implantsinternational.com

Device Dimensions

• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 Millimeter
• Outer Diameter: 64 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
• 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	05051693310773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071583

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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 [Cermet Series III]

• 05051693311121: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm
• 05051693311114: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm
• 05051693311107: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm
• 05051693311091: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm
• 05051693311084: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 54/56 x 44mm
• 05051693311077: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 52 x 41mm
• 05051693311060: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 64/66 x 52mm
• 05051693311053: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm
• 05051693311046: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 54/56 x 39mm
• 05051693311039: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 52 x 41mm
• 05051693311022: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) 10 Deg. Hood 46/48/50 x 39mm
• 05051693311015: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) Neutral 64/66 x 52mm
• 05051693311008: Acetabular Liner for Acetabular Shell ( 36mm Head) (UHMWPE) Neutral 58/60/62 x 48mm
• 05051693310995: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 64/66 x 52mm
• 05051693310988: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 58/60/62 x 48mm
• 05051693310971: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 54/56 x 44mm
• 05051693310964: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) Neutral 52 x 41mm
• 05051693310957: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral64/66 x 48mm
• 05051693310940: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 58/60/62 x 48mm - 28mm Head
• 05051693310933: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 54/56 x44mm - 28mm
• 05051693310926: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 52 x 41mm
• 05051693310919: Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral
• 05051693310902: Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 64/66 x 52mm
• 05051693310896: Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 58/60/62 x 48mm
• 05051693310889: Ceramic Liner for Acetabular Shell ( 36mm Head) (Ceramic) 54/56 x 44mm - 36mm
• 05051693310872: Ceramic Liner for Acetabular Shell ( 32mm Head) (Ceramic) 64/66 x 52mm
• 05051693310865: Ceramic Liner for Acetabular Shell ( 32mm Head) (Ceramic) 58/60/62 x 48mm
• 05051693310858: Ceramic Liner for Acetabular Shell ( 32mm Head) (Ceramic) 54/56 x 44mm
• 05051693310841: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 52 x 41mm
• 05051693310834: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 64/66 x 52mm
• 05051693310827: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 58/60/62 x 48mm
• 05051693310810: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 54/56 x 44mm
• 05051693310803: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 52 x 41mm
• 05051693310797: Ceramic Liner for Acetabular Shell ( 28mm Head) (Ceramic) 46/48/50 x 39mm
• 05051693310780: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 66mm (Dia)
• 05051693310773: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 64mm (Dia)
• 05051693310766: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 62mm (Dia)
• 05051693310759: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 60mm (Dia)
• 05051693310742: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 58mm (Dia)
• 05051693310735: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 56mm (Dia)
• 05051693310728: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 54mm (Dia)
• 05051693310711: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 52mm (Dia)
• 05051693310704: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 50mm (Dia)
• 05051693310698: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 48mm (Dia)
• 05051693310681: Bi-Coated Acetabular Cup, Plasma Coated for uncemented applications (Titanium) 46mm (Dia)