SURGICOUNT

Basic Information

• Brand Name: SURGICOUNT
• Primary DI: 07613327568981
• Version / Model: 0694-002-100
• Catalog Number: 0694-002-100
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-30
• Public Version: 1
• Public Version Date: 2021-08-09
• Public Version Status: New
• Public Device Record Key: 68059722-49cc-4e01-ac24-b02c5628485d

Device Description

+ EMR/QBL APPLICATION

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
JQP	Calculator/data processing module, for clinical use	Clinical Chemistry	862.2100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61906	Electronic surgical sponge-counter	A hand-held battery-powered computerized device intended to be used in the operating room (OR) by professional staff to electronically maintain the count of surgical sponges/swabbing materials during a surgical procedure to prevent swabs from being inadvertently left in a patient. It typically has controls/keyboard, display and built-in bar-code reader, whereby packs of surgical sponges entering the surgical field are intended to be scanned in and counted out. It may include device for battery recharging or connection to a personal computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327568981	GS1

Customer Contacts

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