Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780261513
• Version / Model: 3404441
• Company Name: INTEGRA PAIN MANAGEMENT
• Labeler DUNS: 030370299
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2023-12-05
• Public Version Status: Update
• Public Device Record Key: d0116e52-4fd6-41ee-a31c-84e870fc0fd0
• Distribution End Date: 2019-12-31

Device Description

PAIN TRAY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
59012	Peripheral nerve-block blunt needle access cannula	A sterile flexible tube designed to provide percutaneous access to a peripheral nerve group for the insertion of a nerve-block blunt needle and injection of an anaesthetic/analgesic agent for nerve-block/pain control. It is typically made of plastic and contains a sharp-tipped metal needle to facilitate its introduction which may be guided by fluoroscopy. Once introduced, the sharp needle is intended to be removed so the cannula can be used as a conduit for the nerve-block blunt needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780261517	GS1	CASE	10	Not in Commercial Distribution	2019-12-31
Primary	10381780261513	GS1
Secondary	M61034044411	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage Environment Temperature: 20 C to 25 C (68 F to 77 F)