Optetrak Logic 02-012-65-4019

GUDID 10885862266156

Exactech, Inc.

Tibial insert

• Primary Device ID: 10885862266156
• NIH Device Record Key: d8e9587a-061a-4442-8c72-e690dca71ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optetrak Logic
• Version Model Number: 02-012-65-4019
• Catalog Number: 02-012-65-4019
• Company DUNS: 157565946
• Company Name: Exactech, 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: false
• Serial Number: true
• 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 Dimensions

• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0
• Height: 19 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862266156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150890

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-17
• Device Publish Date: 2022-03-09

On-Brand Devices [Optetrak Logic]

• 10885862265739: 02-010-06-0350
• 10885862265722: 02-010-06-0340
• 10885862265715: 02-010-06-0330
• 10885862265708: 02-010-06-0320
• 10885862265692: 02-010-06-0310
• 10885862265685: 02-010-06-0250
• 10885862265678: 02-010-06-0240
• 10885862265661: 02-010-06-0230
• 10885862265654: 02-010-06-0220
• 10885862265647: 02-010-06-0210
• 10885862255877: 02-012-41-1525
• 10885862255860: 02-012-41-1515
• 10885862255853: 02-012-41-1505
• 10885862175847: 02-010-01-0215
• 10885862169600: 02-012-45-1525
• 10885862169280: 02-012-45-1505
• 10885862167330: 02-012-45-1515
• 10885862158154: 02-010-03-0360
• 10885862158147: 02-010-03-0350
• 10885862158130: 02-010-03-0340
• 10885862158123: 02-010-03-0335
• 10885862158116: 02-010-03-0330
• 10885862158109: 02-010-03-0325
• 10885862158093: 02-010-03-0320
• 10885862158086: 02-010-03-0315
• 10885862158079: 02-010-03-0310
• 10885862158062: 02-010-03-0300
• 10885862158055: 02-010-03-0260
• 10885862158048: 02-010-03-0250
• 10885862158031: 02-010-03-0240
• 10885862158024: 02-010-03-0235
• 10885862158017: 02-010-03-0230
• 10885862158000: 02-010-03-0225
• 10885862157997: 02-010-03-0220
• 10885862157980: 02-010-03-0215
• 10885862157973: 02-010-03-0210
• 10885862157966: 02-010-03-0200
• 10885862004086: 02-012-45-6060
• 10885862004079: 02-012-45-6050
• 10885862004062: 02-012-45-5060
• 10885862004055: 02-012-45-5050
• 10885862004048: 02-012-45-5040
• 10885862004031: 02-012-45-4050
• 10885862004017: 02-012-45-4030
• 10885862004000: 02-012-45-3545
• 10885862003959: 02-012-45-3020
• 10885862003942: 02-012-45-2535
• 10885862003935: 02-012-45-2525
• 10885862003928: 02-012-45-2515
• 10885862003911: 02-012-45-2030