U2 Acetabular Components, Cup Liner 1403-5468

GUDID 04712602343404

U2 Acetabular cup liner,ID 28mm 10°hooded,68mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602343404
• NIH Device Record Key: a1de92d3-97d7-46f1-8da7-5e267cc17ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Components, Cup Liner
• Version Model Number: 1403-5468
• Catalog Number: 1403-5468
• 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

• Outer Diameter: 68 Millimeter
• Lumen/Inner Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602343404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050262

FDA Product Code

• LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2018-08-03
• Device Publish Date: 2015-10-24

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

• 04712602343435: U2 Acetabular cup liner,ID 28mm 10°hooded,74mm
• 04712602343428: U2 Acetabular cup liner,ID 28mm 10°hooded,72mm
• 04712602343411: U2 Acetabular cup liner,ID 28mm 10°hooded,70mm
• 04712602343404: U2 Acetabular cup liner,ID 28mm 10°hooded,68mm
• 04712602343398: U2 Acetabular cup liner,ID 28mm 10°hooded,66mm
• 04712602343381: U2 Acetabular cup liner,ID 28mm 10°hooded,64mm
• 04712602343374: U2 Acetabular cup liner,ID 28mm 10°hooded,62mm
• 04712602343367: U2 Acetabular cup liner,ID 28mm 10°hooded,60mm
• 04712602343350: U2 Acetabular cup liner,ID 28mm 10°hooded,58mm
• 04712602343343: U2 Acetabular cup liner,ID 28mm 10°hooded,56mm
• 04712602343336: U2 Acetabular cup liner,ID 28mm 10°hooded,54mm
• 04712602343329: U2 Acetabular cup liner,ID 28mm 10°hooded,52mm
• 04712602343312: U2 Acetabular cup liner,ID 28mm 10°hooded,50mm
• 04712602343305: U2 Acetabular cup liner,ID 28mm 10°hooded,48mm
• 04712602343251: U2 Acetabular cup liner,ID 26mm 10°hooded,62mm
• 04712602343244: U2 Acetabular cup liner,ID 26mm 10°hooded,60mm
• 04712602343237: U2 Acetabular cup liner,ID 26mm 10°hooded,58mm
• 04712602343220: U2 Acetabular cup liner,ID 26mm 10°hooded,56mm
• 04712602343213: U2 Acetabular cup liner,ID 26mm 10°hooded,54mm
• 04712602343206: U2 Acetabular cup liner,ID 26mm 10°hooded,52mm
• 04712602343190: U2 Acetabular cup liner,ID 26mm 10°hooded,50mm
• 04712602343183: U2 Acetabular cup liner,ID 26mm 10°hooded,48mm
• 04712602343176: U2 Acetabular cup liner,ID 26mm 10°hooded,46mm
• 04712602343169: U2 Acetabular cup liner,ID 26mm 10°hooded,44mm