Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780260288
• Version / Model: 10-2558
• 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: 3
• Public Version Date: 2023-12-05
• Public Version Status: Update
• Public Device Record Key: 7648927f-321f-4285-9c28-0019d24ce787
• Distribution End Date: 2019-12-31

Device Description

CORE BIOPSY 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
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780260282	GS1	CASE	10	Not in Commercial Distribution	2019-12-31
Primary	10381780260288	GS1
Secondary	M6101025581	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)