VV-Plug

Basic Information

• Brand Name: VV-Plug
• Primary DI: 00802526540608
• Version / Model: 667145-750
• Catalog Number: VV-PLUG
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-21
• Public Version: 6
• Public Version Date: 2021-03-19
• Public Version Status: Update
• Public Device Record Key: 09bce02a-5753-4efd-b4df-e1941be187c0
• Distribution End Date: 2020-12-03

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTD	pacemaker lead Adaptor	Cardiovascular	870.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44900	Implantable pulse generator port plug	A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00802526540608	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031164	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.2	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius