U2 Acetabular Components, XPE Cup Liner 1403-1378

GUDID 04712771483468

XPE cup liner, ID32mm, 0°×78mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712771483468
• NIH Device Record Key: d6e433c4-bc8d-4dd2-89c3-5c5beb1631f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Components, XPE Cup Liner
• Version Model Number: 1403-1378
• Catalog Number: 1403-1378
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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

Customer Support Contacts

• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Lumen/Inner Diameter: 32 Millimeter
• Outer Diameter: 78 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712771483468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111546

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-06
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Acetabular Components, XPE Cup Liner]

• 04712771484168: XPE Cup Liner, ID 36 mm, 10°× 80mm
• 04712771484151: XPE Cup Liner, ID 36 mm, 10°× 78mm
• 04712771484144: XPE Cup Liner, ID 36 mm, 10°× 76mm
• 04712771484137: XPE Cup Liner, ID 36 mm, 10°× 74mm
• 04712771484120: XPE Cup Liner, ID 36 mm, 10°× 72mm
• 04712771484113: XPE Cup Liner, ID 36 mm, 10°× 70mm
• 04712771484106: XPE Cup Liner, ID 36 mm, 10°× 68mm
• 04712771484090: XPE Cup Liner, ID 36 mm, 10°× 66mm
• 04712771484083: XPE Cup Liner, ID 36 mm, 10°× 64mm
• 04712771484076: XPE Cup Liner, ID 36 mm, 10°× 62mm
• 04712771484069: XPE Cup Liner, ID 36 mm, 10°× 60mm
• 04712771484052: XPE Cup Liner, ID 36 mm, 10°× 58mm
• 04712771484045: XPE Cup Liner, ID 36 mm, 10× 56mm
• 04712771484038: XPE Cup Liner, ID 36 mm, 10× 54mm
• 04712771484007: XPE Cup Liner, ID 32 mm, 10°× 80mm
• 04712771483994: XPE Cup Liner, ID 32 mm, 10°× 78mm
• 04712771483987: XPE Cup Liner, ID 32 mm, 10°× 76mm
• 04712771483970: XPE Cup Liner, ID 32 mm, 10°× 74mm
• 04712771483963: XPE Cup Liner, ID 32 mm, 10°× 72mm
• 04712771483956: XPE Cup Liner, ID 32 mm, 10°× 70mm
• 04712771483949: XPE Cup Liner, ID 32 mm, 10°× 68mm
• 04712771483932: XPE Cup Liner, ID 32 mm, 10°× 66mm
• 04712771483925: XPE Cup Liner, ID 32 mm, 10°× 64mm
• 04712771483918: XPE Cup Liner, ID 32 mm, 10°× 62mm
• 04712771483901: XPE Cup Liner, ID 32 mm, 10°× 60mm
• 04712771483895: XPE Cup Liner, ID 32 mm, 10°× 58mm
• 04712771483888: XPE Cup Liner, ID 32 mm, 10°× 56mm
• 04712771483871: XPE Cup Liner, ID 32 mm, 10°× 54mm
• 04712771483864: XPE Cup Liner, ID 32 mm, 10°× 52mm
• 04712771483857: XPE Cup Liner, ID 32 mm, 10°× 50mm
• 04712771483826: XPE Cup Liner, ID 28 mm, 10°× 80mm
• 04712771483819: XPE Cup Liner, ID 28 mm, 10°× 78mm
• 04712771483802: XPE Cup Liner, ID 28 mm, 10°× 76mm
• 04712771483796: XPE Cup Liner, ID 28 mm, 10°× 74mm
• 04712771483789: XPE Cup Liner, ID 28 mm, 10°× 72mm
• 04712771483772: XPE Cup Liner, ID 28 mm, 10°× 70mm
• 04712771483765: XPE Cup Liner, ID 28 mm, 10°× 68mm
• 04712771483758: XPE Cup Liner, ID 28 mm, 10°× 66mm
• 04712771483741: XPE Cup Liner, ID 28 mm, 10°× 64mm
• 04712771483734: XPE Cup Liner, ID 28 mm, 10°× 62mm
• 04712771483727: XPE Cup Liner, ID 28 mm, 10°× 60mm
• 04712771483710: XPE Cup Liner, ID 28 mm, 10× 58mm
• 04712771483703: XPE Cup Liner, ID 28 mm, 10°× 56mm
• 04712771483697: XPE Cup Liner, ID 28 mm, 10°× 54mm
• 04712771483680: XPE Cup Liner, ID 28 mm, 10°× 52mm
• 04712771483673: XPE Cup Liner, ID 28 mm, 10°× 50mm
• 04712771483666: XPE Cup Liner, ID 28 mm, 10°× 48mm
• 04712771483659: XPE Cup Liner, ID 28 mm, 10°× 46mm
• 04712771483642: XPE Cup Liner, ID 28 mm, 10°× 44mm
• 04712771483635: XPE cup liner, ID36mm, 0°×80mm