U2 Femoral Head 1206-2436-RC

GUDID 04711605586962

U2 Femoral head trial, Ø36mm, +5mm

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial

• Primary Device ID: 04711605586962
• NIH Device Record Key: fbbbd048-d75a-4042-b2bf-f48c597b01a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Femoral Head
• Version Model Number: 1206-2436-RC
• Catalog Number: 1206-2436-RC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605586962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162957

FDA Product Code

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

Sterilization

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

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

[04711605586962]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-24
• Device Publish Date: 2022-06-16

On-Brand Devices [U2 Femoral Head]

• 04711605581165: U2 Femoral head trial, Ø36mm, +10mm
• 04711605581158: U2 Femoral head trial, Ø32mm, +10mm
• 04711605581141: U2 Femoral head trial, Ø28mm, +10mm
• 04711605581134: U2 Femoral head trial, Ø26mm, +9mm
• 04711605581127: U2 Femoral head trial, Ø22mm, +9mm
• 04711605581110: U2 Femoral head trial, Ø36mm, +7.5mm
• 04711605581103: U2 Femoral head trial, Ø32mm, +7.5mm
• 04711605581097: U2 Femoral head trial, Ø28mm, +7.5mm
• 04711605581080: U2 Femoral head trial, Ø26mm, +6mm
• 04711605581073: U2 Femoral head trial, Ø22mm, +6mm
• 04711605581066: U2 Femoral head trial, Ø36mm, +5mm
• 04711605581059: U2 Femoral head trial, Ø32mm, +5mm
• 04711605581042: U2 Femoral head trial, Ø28mm, +5mm
• 04711605581035: U2 Femoral head trial, Ø26mm, +3mm
• 04711605581028: U2 Femoral head trial, Ø22mm, +3mm
• 04711605581011: U2 Femoral head trial, Ø36mm, +2.5mm
• 04711605581004: U2 Femoral head trial, Ø32mm, +2.5mm
• 04711605580991: U2 Femoral head trial, Ø28mm, +2.5mm
• 04711605580984: U2 Femoral head trial, Ø36mm, +0mm
• 04711605580977: U2 Femoral head trial, Ø32mm, +0mm
• 04711605580960: U2 Femoral head trial, Ø28mm, +0mm
• 04711605580953: U2 Femoral head trial, Ø26mm, +0mm
• 04711605580946: U2 Femoral head trial, Ø22mm, +0mm
• 04711605580939: U2 Femoral head trial, Ø36mm, -3mm
• 04711605580922: U2 Femoral head trial, Ø32mm, -3mm
• 04711605580915: U2 Femoral head trial, Ø28mm, -3mm
• 04711605580908: U2 Femoral head trial, Ø26mm, -2mm
• 04711605587068: U2 Femoral head trial, Ø36mm, +10mm
• 04711605587051: U2 Femoral head trial, Ø32mm, +10mm
• 04711605587044: U2 Femoral head trial, Ø28mm, +10mm
• 04711605587037: U2 Femoral head trial, Ø26mm, +9mm
• 04711605587020: U2 Femoral head trial, Ø22mm, +9mm
• 04711605587013: U2 Femoral head trial, Ø36mm, +7.5mm
• 04711605587006: U2 Femoral head trial, Ø32mm, +7.5mm
• 04711605586993: U2 Femoral head trial, Ø28mm, +7.5mm
• 04711605586986: U2 Femoral head trial, Ø26mm, +6mm
• 04711605586979: U2 Femoral head trial, Ø22mm, +6mm
• 04711605586962: U2 Femoral head trial, Ø36mm, +5mm
• 04711605586955: U2 Femoral head trial, Ø32mm, +5mm
• 04711605586948: U2 Femoral head trial, Ø28mm, +5mm
• 04711605586931: U2 Femoral head trial, Ø26mm, +3mm
• 04711605586924: U2 Femoral head trial, Ø22mm, +3mm
• 04711605586917: U2 Femoral head trial, Ø36mm, +2.5mm
• 04711605586900: U2 Femoral head trial, Ø32mm, +2.5mm
• 04711605586894: U2 Femoral head trial, Ø28mm, +2.5mm
• 04711605586887: U2 Femoral head trial, Ø36mm, +0mm
• 04711605586870: U2 Femoral head trial, Ø32mm, +0mm
• 04711605586863: U2 Femoral head trial, Ø28mm, +0mm
• 04711605586856: U2 Femoral head trial, Ø26mm, +0mm
• 04711605586849: U2 Femoral head trial, Ø22mm, +0mm