Bio Protech

Basic Information

• Brand Name: Bio Protech
• Primary DI: 00817120020296
• Version / Model: 9552F
• Company Name: BIO PROTECH USA, INC.
• Labeler DUNS: 789127011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-28
• Public Version: 4
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: 4f1cfd4d-9c2d-4cb0-bb5e-8819ff01d1eb

Device Description

9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch, 40 pouches in Master Case) (Do Not Use)

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58494	Electrosurgical return electrode, single-use	A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817120020290	GS1	Master Case	2	Not in Commercial Distribution	2017-06-06
Package	10817120020293	GS1	Inner Box	40	Not in Commercial Distribution	2017-06-06
Primary	00817120020296	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073360	000