Integra® Padgett®

Basic Information

• Brand Name: Integra® Padgett®
• Primary DI: 10381780278016
• Version / Model: DP0005
• Catalog Number: DP0005
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Labeler DUNS: 963856096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-09
• Public Version: 5
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 3ed806d1-4dc6-4057-b1c6-e60c6b868e83

Device Description

Integra® Padgett® Dermatomes Power supply (120V) Model PI - USA/Canada Only

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFD	DERMATOME	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248DP00051	HIBCC
Primary	10381780278016	GS1

Customer Contacts

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