U2 Acetabular Cup Liner 1403-5046

GUDID 04712771506969

U2 Acetabular cup liner,ID 26mm 10°hooded,46mm (for CCM Cup)

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712771506969
• NIH Device Record Key: b929e40e-ff06-4c37-aa67-26d342b84e6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Cup Liner
• Version Model Number: 1403-5046
• Catalog Number: 1403-5046
• 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: 46 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712771506969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022520

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: 2018-08-02
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Acetabular Cup Liner]

• 04712771507041: U2 Acetabular cup liner,ID 28mm 10°hooded,62mm (for CCM Cup)
• 04712771507034: U2 Acetabular cup liner,ID 28mm 10°hooded,60mm (for CCM Cup)
• 04712771507027: U2 Acetabular cup liner,ID 28mm 10°hooded,58mm (for CCM Cup)
• 04712771507010: U2 Acetabular cup liner,ID 28mm 10°hooded,56mm (for CCM Cup)
• 04712771507003: U2 Acetabular cup liner,ID 28mm 10°hooded,54mm (for CCM Cup)
• 04712771506990: U2 Acetabular cup liner,ID 28mm 10°hooded,52mm (for CCM Cup)
• 04712771506983: U2 Acetabular cup liner,ID 28mm 10°hooded,50mm (for CCM Cup)
• 04712771506976: U2 Acetabular cup liner,ID 28mm 10°hooded,48mm (for CCM Cup)
• 04712771506969: U2 Acetabular cup liner,ID 26mm 10°hooded,46mm (for CCM Cup)
• 04711605560986: U2 Acetabular cup liner,ID 26mm 10°hooded,44mm (for CCM Cup)