NA

Basic Information

• Brand Name: NA
• Primary DI: 00763000059446
• Version / Model: 080118
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-22
• Public Version: 2
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: ed6bfa0c-3bb4-4afd-9379-26d5e427eb1b

Device Description

ADHESIVE 080118 MEDICAL OUS US EIFU

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KFJ	Materials, repair or replacement, pacemaker	Cardiovascular	870.3710	3

GMDN Terms

Code	Name	Definition	Implantable	Status
46219	Medical device adhesive	A substance primarily intended to promote the bonding of two surfaces in the manufacture of medical devices (e.g., active implantable devices). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000059446	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P830061	073

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 32 Degrees Celsius