PL8 4722309R

GUDID 08052990970230

CITIEFFE SRL

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08052990970230
• NIH Device Record Key: 19f1e4a3-1e94-4853-b3ca-2d116d96100f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PL8
• Version Model Number: Wrist reconstruction plate, S right
• Catalog Number: 4722309R
• Company DUNS: 431406875
• Company Name: CITIEFFE SRL
• 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: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052990970230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180150

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2018-09-01

On-Brand Devices [PL8]

• 08051739534771: Kirschner wire, ø1.2x120mm
• 08051739534764: Drill bit, ø2.5x150mm
• 08051739534757: Drill bit, ø1.9x150mm
• 08052990970636: Drill guide, ø2.5mm
• 08052990972692: Support screws, ø2.5mm
• 08052990971282: Wrist instrument box, empty
• 08052990970308: Wrist reconstruction plate, XL left
• 08052990970292: Wrist reconstruction plate, XL right
• 08052990970285: Wrist reconstruction plate, L left
• 08052990970278: Wrist reconstruction plate, L right
• 08052990970261: Wrist reconstruction plate, M left
• 08052990970254: Wrist reconstruction plate, M right
• 08052990970247: Wrist reconstruction plate, S left
• 08052990970230: Wrist reconstruction plate, S right
• 08052990970575: Kirschner wire, ø1.2x120mm
• 08052990970544: Cortical screw ø2.5mm L30mm
• 08052990970537: Cortical screw ø2.5mm L28mm
• 08052990970520: Cortical screw ø2.5mm L26mm
• 08052990970513: Cortical screw ø2.5mm L24mm
• 08052990970506: Cortical screw ø2.5mm L22mm
• 08052990970490: Cortical screw ø2.5mm L20mm
• 08052990970483: Cortical screw ø2.5mm L18mm
• 08052990970476: Cortical screw ø2.5mm L16mm
• 08052990970469: Cortical screw ø2.5mm L14mm
• 08052990970452: Cortical screw ø2.5mm L12mm
• 08052990970445: Cortical screw ø2.5mm L10mm
• 08052990970438: Cortical screw ø2.5mm L8mm
• 08052990970421: Locking screw ø2.5mm L30mm
• 08052990970414: Locking screw ø2.5mm L28mm
• 08052990970407: Locking screw ø2.5mm L26mm
• 08052990970391: Locking screw ø2.5mm L24mm
• 08052990970384: Locking screw ø2.5mm L22mm
• 08052990970377: Locking screw ø2.5mm L20mm
• 08052990970360: Locking screw ø2.5mm L18mm
• 08052990970353: Locking screw ø2.5mm L16mm
• 08052990970346: Locking screw ø2.5mm L14mm
• 08052990970339: Locking screw ø2.5mm L12mm
• 08052990970322: Locking screw ø2.5mm L10mm
• 08052990970315: Locking screw ø2.5mm L8mm