ADVANSYS DLP 181031SND

GUDID 10381780043997

The Newdeal sterile DLP Plate consists of an osteosynthesis plate, available in different sizes, and is implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.

NEWDEAL

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: 10381780043997
• NIH Device Record Key: c9bb4a52-6d7b-4e2c-9a14-afe30d5bc60c
• Commercial Distribution Discontinuation: 2026-11-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANSYS DLP
• Version Model Number: 181031SND
• Catalog Number: 181031SND
• Company DUNS: 536935331
• Company Name: NEWDEAL
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780043997 [Primary]
HIBCC	M248181031SND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060474

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: 6
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-10-09

On-Brand Devices [ADVANSYS DLP]

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• 10381780044000: The Newdeal sterile DLP Plate consists of an osteosynthesis plate, available in different sizes,
• 10381780043997: The Newdeal sterile DLP Plate consists of an osteosynthesis plate, available in different sizes,
• 10381780043980: The Newdeal sterile DLP Plate consists of an osteosynthesis plate, available in different sizes,
• 10381780043973: The Newdeal sterile DLP Plate consists of an osteosynthesis plate, available in different sizes,
• 10381780043966: The Newdeal sterile DLP Plate consists of an osteosynthesis plate, available in different sizes,