iASSIST

Basic Information

• Brand Name: iASSIST
• Primary DI: 00889024305243
• Version / Model: 20-8011-001-00
• Catalog Number: 20-8011-001-00
• Company Name: Orthosoft Inc
• Labeler DUNS: 205670032
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 6
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 98e0837e-0731-4461-ba3f-294f54597275
• Distribution End Date: 2020-09-30

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58927	Orthopaedic prosthesis implantation positioning instrument, single-use	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024305243	GS1
Unit of Use	00889024466371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K122326	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Humidity: 0%/80%
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -18 – 49 Degrees Celsius