Emprint SX

Basic Information

• Brand Name: Emprint SX
• Primary DI: 10884521703339
• Version / Model: CABK8816
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-13
• Public Version: 5
• Public Version Date: 2022-05-10
• Public Version Status: Update
• Public Device Record Key: b9779e7e-5662-4524-aa93-17cf2e3c9de8

Device Description

Open Ultrasound Tracking Sensor. For use with BK Medical. Type 8816 open ultrasound probes

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES	General, Plastic Surgery	878.4400	2
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58138	Non-evacuated blood collection tube IVD, clot activator/separator	A non-evacuated glass or plastic tube, sealed with a stopper, containing a clot activator and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521703339	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit