Kyocera Medical Technologies, Inc. 1416-028-044

GUDID 00841523105403

Bipolar Implant 44mm OD - 28mm ID

KYOCERA MEDICAL TECHNOLOGIES, INC.

Femoral head bipolar component

• Primary Device ID: 00841523105403
• NIH Device Record Key: cab60318-9d9b-49a0-9c1f-b28685b47109
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kyocera Medical Technologies, Inc.
• Version Model Number: Bipolar Hip
• Catalog Number: 1416-028-044
• Company DUNS: 116995646
• Company Name: KYOCERA MEDICAL TECHNOLOGIES, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841523105403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131354

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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: 5
• Public Version Date: 2019-07-25
• Device Publish Date: 2015-10-28

On-Brand Devices [Kyocera Medical Technologies, Inc. ]

• 00841523149155: Straight Implant Trial 34mm x 11mm x12mm
• 00841523130054: 38 x 30 Implant Caddy, 7° PEEK
• 00841523119851: 9mm Trial, 34 X 28, 12° Lordosis
• 00841523119844: 9mm Trial, 30 X 26, 12° Lordosis
• 00841523146079: Tesera T, Straight Trial 28mm x 10mm x 16mm, Bullet
• 00841523146062: Tesera T, Straight Trial 28mm x 10mm x 15mm, Bullet
• 00841523146055: Tesera T, Straight Trial 28mm x 10mm x 14mm, Bullet
• 00841523146048: Tesera T, Straight Trial 28mm x 10mm x 13mm, Bullet
• 00841523146031: Tesera T, Straight Trial 28mm x 10mm x 12mm, Bullet
• 00841523146024: Tesera T, Straight Trial 28mm x 10mm x 11mm, Bullet
• 00841523146017: Tesera T, Straight Trial 28mm x 10mm x 10mm, Bullet
• 00841523146000: Tesera T, Straight Trial 28mm x 10mm x 9mm, Bullet
• 00841523145997: Tesera T, Straight Trial 28mm x 10mm x 8mm, Bullet
• 00841523145980: Tesera T, Straight Trial 28mm x 10mm x 7mm, Bullet
• 00841523150625: Pituitary Rongeur, 4mm x 10mm
• 00841523150618: Pituitary Rongeur, 4mm x 10mm
• 00841523150601: Posterior Paddle Sizer, 15mm
• 00841523150595: Posterior Paddle Sizer, 14mm
• 00841523150588: Posterior Paddle Sizer, 13mm
• 00841523150571: Posterior Paddle Sizer, 12mm
• 00841523150564: Posterior Paddle Sizer, 11mm
• 00841523150557: Posterior Paddle Sizer, 10mm
• 00841523150540: Posterior Paddle Sizer, 9mm
• 00841523150533: Posterior Paddle Sizer, 8mm
• 00841523150526: Posterior Paddle Sizer, 7mm
• 00841523150519: Posterior Paddle Sizer, 6mm
• 00841523150502: Tesera C Cage Inserter
• 00841523150496: Distal Femoral Cut Block
• 00841523150489: Distal Femoral Alignment Guide Tower
• 00841523148622: PS Box Gauge
• 00841523148615: A200 PS Notch Cutting Guide, Size 7
• 00841523148608: A200 PS Notch Cutting Guide, Size 6
• 00841523148592: A200 PS Notch Cutting Guide, Size 5
• 00841523148585: A200 PS Notch Cutting Guide, Size 4
• 00841523148578: A200 PS Notch Cutting Guide, Size 3
• 00841523148561: A200 PS Notch Cutting Guide, Size 2
• 00841523148554: A200 PS Notch Cutting Guide, Size 1
• 00841523147649: PS Tibia Insert Trial Size C, 23mm - Right
• 00841523147632: PS Tibia Insert Trial Size C, 20mm - Right
• 00841523147625: PS Tibia Insert Trial Size C, 17mm - Right
• 00841523147618: PS Tibia Insert Trial Size C, 14mm - Right
• 00841523147601: PS Tibia Insert Trial Size C, 12mm - Right
• 00841523147595: PS Tibia Insert Trial Size C, 10mm - Right
• 00841523147588: PS Tibia Insert Trial Size B, 23mm - Right
• 00841523147571: PS Tibia Insert Trial Size B, 20mm - Right
• 00841523147564: PS Tibia Insert Trial Size B, 17mm - Right
• 00841523147557: PS Tibia Insert Trial Size B, 14mm - Right
• 00841523147540: PS Tibia Insert Trial Size B, 12mm - Right
• 00841523147533: PS Tibia Insert Trial Size B, 10mm - Right
• 00841523147526: PS Tibia Insert Trial Size A, 23mm - Right