Consensus Hip System 1020-0-3860

GUDID 00840286804981

Bipolar Assembly, 28mm×60mm, +5mm

Shalby Advanced Technologies, Inc.

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 00840286804981
• NIH Device Record Key: f509f8a7-91d0-48b1-877b-970c67115205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consensus Hip System
• Version Model Number: 1020-0-3860
• Catalog Number: 1020-0-3860
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286804981 [Primary]

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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: 2022-01-24
• Device Publish Date: 2022-01-15

On-Brand Devices [Consensus Hip System]

• 00840286801324: Acetabular Insert, 32mm ID, 68mm
• 00840286801317: Acetabular Insert, 32mm ID, 66mm
• 00840286801300: Acetabular Insert, 32mm ID, 64mm
• 00840286801294: Acetabular Insert, 32mm ID, 62mm
• 00840286801287: Acetabular Insert, 32mm ID, 60mm
• 00840286801270: Acetabular Insert, 32mm ID, 58mm
• 00840286801263: Acetabular Insert, 32mm ID, 56mm
• 00840286801256: Acetabular Insert, 32mm ID, 54mm
• 00840286801249: Acetabular Insert, 32mm ID, 52mm
• 00840286800952: Acetabular Insert, 20° Hood, 36mm ID, 68mm
• 00840286800945: Acetabular Insert, 20° Hood, 32mm ID, 68mm
• 00840286800938: Acetabular Insert, 20° Hood, 32mm ID, 66mm
• 00840286800921: Acetabular Insert, 20° Hood, 32mm ID, 64mm
• 00840286800914: Acetabular Insert, 20° Hood, 32mm ID, 62mm
• 00840286800907: Acetabular Insert, 20° Hood, 32mm ID, 60mm
• 00840286800891: Acetabular Insert, 20° Hood, 32mm ID, 58mm
• 00840286800884: Acetabular Insert, 20° Hood, 32mm ID, 56mm
• 00840286800877: Acetabular Insert, 20° Hood, 32mm ID, 54mm
• 00840286800860: Acetabular Insert, 20° Hood, 32mm ID, 52mm
• 00840286800716: Distal Centralizer, 24mm
• 00840286800709: Distal Centralizer, 23mm
• 00840286800693: Distal Centralizer, 22mm
• 00840286800686: Distal Centralizer, 21mm
• 00840286800679: Distal Centralizer, 20mm
• 00840286800662: Distal Centralizer, 19mm
• 00840286800655: Distal Centralizer, 18mm
• 00840286805193: Bipolar Assembly, 22mm×56mm, +6mm
• 00840286805186: Bipolar Assembly, 22mm×55mm, +6mm
• 00840286805179: Bipolar Assembly, 22mm×54mm, +6mm
• 00840286805162: Bipolar Assembly, 22mm×53mm, +6mm
• 00840286805155: Bipolar Assembly, 22mm×52mm, +6mm
• 00840286805148: Bipolar Assembly, 22mm×51mm, +6mm
• 00840286805131: Bipolar Assembly, 22mm×50mm, +6mm
• 00840286805124: Bipolar Assembly, 22mm×49mm, +6mm
• 00840286805117: Bipolar Assembly, 22mm×48mm, +6mm
• 00840286805100: Bipolar Assembly, 22mm×47mm, +6mm
• 00840286805094: Bipolar Assembly, 22mm×46mm, +6mm
• 00840286805087: Bipolar Assembly, 22mm×45mm, +6mm
• 00840286805070: Bipolar Assembly, 22mm×44mm, +6mm
• 00840286805063: Bipolar Assembly, 22mm×43mm, +6mm
• 00840286805056: Bipolar Assembly, 22mm×42mm, +6mm
• 00840286805049: Bipolar Assembly, 22mm×41mm, +6mm
• 00840286805032: Bipolar Assembly, 22mm×40mm, +6mm
• 00840286805025: Bipolar Assembly, 22mm×39mm, +6mm
• 00840286805018: Bipolar Assembly, 22mm×38mm, +6mm
• 00840286805001: Bipolar Assembly, 28mm×62mm, +5mm
• 00840286804998: Bipolar Assembly, 28mm×61mm, +5mm
• 00840286804981: Bipolar Assembly, 28mm×60mm, +5mm
• 00840286804974: Bipolar Assembly, 28mm×59mm, +5mm
• 00840286804967: Bipolar Assembly, 28mm×58mm, +5mm