Medtronic 81800031

GUDID 00860014655944

The Sterile Pack A Drape is intended to cover the Anatomic Access Arm to serve as a sterile barrier.

Quantum Ops, Inc.

Medical equipment/instrument drape, single-use

• Primary Device ID: 00860014655944
• NIH Device Record Key: 6f01e635-8217-4ba9-98f9-e7b7da09595c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic
• Version Model Number: Sterile Pack A³ Drape PK 1
• Catalog Number: 81800031
• Company DUNS: 036253884
• Company Name: Quantum Ops, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014655944 [Primary]

FDA Product Code

• BTX: Board, Arm (With Cover), Sterile

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [Medtronic]

• 00860014655944: The Sterile Pack A Drape is intended to cover the Anatomic Access Arm to serve as a sterile barr
• 00860012987870: Adapter for the AAA to connect to the Anatomic Access retractor, or other retractor adapters
• 00860012987863: This device aims to improve surgical efficiency and precision of various spine surgeries by prov