SYRINGE ATR INFLATION HP

GUDID 00763000557065

SYRINGE A08E-ATR INFLATION HP

MEDTRONIC SOFAMOR DANEK, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00763000557065
• NIH Device Record Key: 87ea10e3-43de-40f6-a647-86bbac16a2c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYRINGE ATR INFLATION HP
• Version Model Number: A08E-ATR
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000557065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020333

FDA Product Code

• DXT: Injector and syringe, angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-12
• Device Publish Date: 2023-06-03

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000780623 - MSB|CD HORIZON® Spinal System: 2025-02-04 SCREW 54740105545 4.75 HA MAS 5.5X45 CC
• 00763000872243 - MSB|CD HORIZON® Spinal System: 2025-02-04 SCREW 54740107550 4.75 HA MAS 7.5X50 CC
• 00763000872250 - MSB|CD HORIZON® Spinal System: 2025-02-04 SCREW 54740107545 4.75 HA MAS 7.5X45 CC
• 00763000872298 - MSB|CD HORIZON® Spinal System: 2025-02-04 SCREW 54740106545 4.75 HA MAS 6.5X45 CC
• 00763000700249 - Medtronic Reusable Instruments: 2025-02-03 DRIVER T25 EX981000033 RETAINING STH
• 00763000700256 - Medtronic Reusable Instruments: 2025-02-03 AWL EX981000035 ANGLED
• 00763000700263 - Medtronic Reusable Instruments: 2025-02-03 DRIVER T25 EX981000036 RETAINING 40DEG
• 00763000700270 - Medtronic Reusable Instruments: 2025-02-03 DRIVER T25 EX981000037 RETAINING BALL JT