Full XPE cup 1302-3248

GUDID 04711605568791

Full XPE cup, ID 32mm, OD 48mm

UNITED ORTHOPEDIC CORP.

Polyethylene acetabulum prosthesis

• Primary Device ID: 04711605568791
• NIH Device Record Key: 3372831f-570c-45e9-8410-f3422bec3cc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full XPE cup
• Version Model Number: 1302-3248
• Catalog Number: 1302-3248
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605568791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163441

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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: 2018-08-08
• Device Publish Date: 2017-10-06

On-Brand Devices [Full XPE cup]

• 04711605579247: Full XPE cup, ID 32mm, OD 62mm
• 04711605579230: Full XPE cup, ID 32mm, OD 60mm
• 04711605579223: Full XPE cup, ID 32mm, OD 58mm
• 04711605579216: Full XPE cup, ID 32mm, OD 56mm
• 04711605579209: Full XPE cup, ID 32mm, OD 54mm
• 04711605579193: Full XPE cup, ID 32mm, OD 52mm
• 04711605573740: Full XPE cup, ID 26mm, OD 42mm
• 04711605568869: Full XPE cup, ID 36mm, OD 62mm
• 04711605568852: Full XPE cup, ID 36mm, OD 60mm
• 04711605568845: Full XPE cup, ID 36mm, OD 58mm
• 04711605568838: Full XPE cup, ID 36mm, OD 56mm
• 04711605568821: Full XPE cup, ID 36mm, OD 54mm
• 04711605568814: Full XPE cup, ID 36mm, OD 52mm
• 04711605568807: Full XPE cup, ID 32mm, OD 50mm
• 04711605568791: Full XPE cup, ID 32mm, OD 48mm
• 04711605568784: Full XPE cup, ID 28mm, OD 46mm
• 04711605568777: Full XPE cup, ID 28mm, OD 44mm
• 04719886894349: Cup pusher head, 36mm
• 04719886894332: Cup pusher head, 32mm
• 04719886894325: Cup pusher head, 28mm
• 04719886894295: Curved cup pusher
• 04719886894288: Positioner plate, L
• 04719886894271: Positioner plate, M
• 04719886894264: Positioner plate, S
• 04719886894257: Positioner plate, XS
• 04719886894240: Positioner head, L
• 04719886894233: Positioner head, M
• 04719886894226: Positioner head, S
• 04719886894219: Positioner head, XS
• 04719886894202: Full XPE cup positioner handle