Integra® 3403970

GUDID 10381780261247

Discogram Tray

INTEGRA PAIN MANAGEMENT

Interventional radiology percutaneous-access procedure kit Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use Interventional radiology percutaneous-access kit, single-use

• Primary Device ID: 10381780261247
• NIH Device Record Key: 91039fb5-41a0-4913-aa43-2d896985a8fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: 3403970
• Catalog Number: 3403970
• Company DUNS: 030370299
• Company Name: INTEGRA PAIN MANAGEMENT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780261247 [Previous]
GS1	10381780430049 [Primary]
GS1	30381780430043 [Package]; Contains: 10381780430049; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960082

FDA Product Code

• IZG: System, x-ray, photofluorographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-16
• Device Publish Date: 2018-06-20

On-Brand Devices [Integra®]

• 30381780527088: Trapsystem® Bone Marrow Biopsy & Aspiration Tray
• 30381780527071: Bone Marrow Biopsy Tray
• 10381780202929: Basic Biopsy Tray
• 10381780511175: Single Shot Epidural Tray
• 30381780511292: Myelogram Tray
• 10381780431725: Single Shot Epidural Tray
• 10381780262176: Combined Spinal/Epidural Tray
• 30381780491310: Single Shot Epidural Tray
• 30381780486767: Single Shot Epidural Tray
• 30381780479585: Single Shot Epidural Tray
• 30381780471305: Single Shot Epidural Tray
• 30381780471275: Single Shot Epidural Tray
• 10381780464969: Single Shot Epidural Tray
• 30381780464963: Single Shot Epidural Tray
• 30381780457293: Single Shot Epidural Tray
• 30381780441322: Single Shot Epidural Tray
• 10381780357476: Transforaminal Tray
• 10381780357469: Single Shot Epidural Tray
• 10381780356103: Single Shot Epidural Tray
• 10381780356097: Single Shot Epidural Tray
• 30381780431774: Epidural Pain Tray
• 30381780431743: Single Shot Epidural Tray
• 30381780431736: Single Shot Epidural Tray
• 30381780431729: Single Shot Epidural Tray
• 10381780263852: Complete Single Shot Tray
• 10381780263807: Single Shot Epidural Tray
• 10381780262497: Single Shot Epidural Tray
• 30381780431651: Single Shot Epidural Tray
• 30381780431644: Single Shot Epidural Tray
• 10381780265078: Myelogram Tray
• 10381780264965: Single Shot Epidural Tray
• 10381780264897: Single Shot Epidural Tray
• 10381780264880: Epidural Painpak
• 10381780264866: Epidural Pain Tray
• 10381780264736: Single Shot Epidural Tray
• 10381780264651: Single Shot Epidural Tray
• 10381780264637: Single Shot Epidural Tray 20G X 3.5"
• 10381780264620: Single Shot Epidural Tray 17G X 3.5
• 10381780263838: Single Shot Epidural Tray
• 10381780263821: Epidural Lumbar Tray
• 10381780263753: Single Shot Epidural Tray
• 10381780263746: Single Shot Epidural Tray
• 10381780263739: Single Shot Epidural Tray
• 10381780263692: Single Shot Epidural Tray
• 10381780263593: Single Shot Epidural Tray
• 10381780263555: Epidural Tray
• 10381780263395: Single Shot Epidural Tray
• 10381780263302: Single Shot Epidural Tray
• 10381780263234: Single Shot Epidural Tray
• 10381780263203: Epidural Tray, Single Shot, 17G Tuohy