Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780430797
• Version / Model: CUS1221-02
• Catalog Number: CUS1221-02
• Company Name: INTEGRA PAIN MANAGEMENT
• Labeler DUNS: 030370299
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-20
• Public Version: 4
• Public Version Date: 2023-12-05
• Public Version Status: Update
• Public Device Record Key: 28a03855-a283-44c7-bafe-3ff549f7f124
• Distribution End Date: 2019-12-31

Device Description

Universal Block 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

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
Previous	10381780262763	GS1
Package	30381780430791	GS1	Case	10	Not in Commercial Distribution	2019-12-31
Primary	10381780430797	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960100	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Use if Package is Damaged