iASSIST 20-8011-002-00

GUDID 00889024305250

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 00889024305250
• NIH Device Record Key: 8f1989c8-d4e5-450a-b873-7fd4ed423cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iASSIST
• Version Model Number: 20-8011-002-00
• Catalog Number: 20-8011-002-00
• Company DUNS: 205670032
• Company Name: Orthosoft Inc
• Device Count: 2
• 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: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%
• Handling Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: 0%/80%

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024305250 [Primary]
GS1	00889024466388 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141601

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-07

On-Brand Devices [iASSIST]

• 00889024305496: 20-8011-065-00
• 00889024305489: 20-8011-064-00
• 00889024305472: 20-8011-063-00
• 00889024305250: 20-8011-002-00
• 00889024305243: 20-8011-001-00
• 00889024276185: 20-8000-000-20
• 00889024211636: 302.4001