NA

Basic Information

• Brand Name: NA
• Primary DI: 07613327512175
• Version / Model: 0101-0002
• Catalog Number: 0101-0002
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-22
• Public Version: 1
• Public Version Date: 2020-12-30
• Public Version Status: New
• Public Device Record Key: e4f0deb7-be4c-4ceb-acf1-1ffc8f71fca7

Device Description

ADAPT 2.1 for Gamma3 SW

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
60723	Medical image management system	A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327512175	GS1

Premarket Submissions

Submission Number	Supplement Number
K202749	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 85 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity