Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780431350
• Version / Model: CUS701-01
• Catalog Number: CUS701-01
• 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: 3
• Public Version Date: 2023-12-05
• Public Version Status: Update
• Public Device Record Key: 3b3cc7ce-fedd-48de-a87f-ba9e7731d100
• Distribution End Date: 2019-12-31

Device Description

Single Shot Epidural 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
61911	Epidural anaesthesia set, medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	10381780263739	GS1
Package	30381780431354	GS1	Case	10	Not in Commercial Distribution	2019-12-31
Primary	10381780431350	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945484	000

Storage Conditions

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