ORTHOLOC 3Di CROSSCHECK

GUDID 00840420187796

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840420187796
• NIH Device Record Key: 5e2a9856-6b9f-44e3-8da9-4c80a5422bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOLOC 3Di CROSSCHECK
• Version Model Number: 582SYPX1
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: true
• 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: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420187796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152974

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [ORTHOLOC 3Di CROSSCHECK]

• 00889797040860: 5820CX25
• 00840420187918: 582SX3540
• 00840420187901: 582SX3538
• 00840420187895: 582SX3536
• 00840420187888: 582SX3534
• 00840420187871: 582SX3532
• 00840420187864: 582SX3530
• 00840420187857: 582SX3528
• 00840420187840: 582SX3526
• 00840420187833: 582SX3524
• 00840420187826: 582SX3522
• 00840420187819: 582SX3520
• 00840420187802: 582SX3518
• 00840420187796: 582SYPX1
• 00840420187765: 582SUTN5
• 00840420187727: 582SMPX1R
• 00840420187710: 582SMPX1L
• 00840420187703: 582SLPX2R
• 00840420187697: 582SLPX2L
• 00840420187680: 582SLPX0R
• 00840420187673: 582SLPX0L