Adaptable 804-33-006

GUDID 00860012987818

The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by extending the Rail of the Back Side of the T-Max to install the Adaptable Arm, achieving a complete exposure and mobility on the patient arm.

Quantum Ops, Inc.

Arm procedure positioner, reusable

• Primary Device ID: 00860012987818
• NIH Device Record Key: ecabe90c-8a4a-457c-9a46-8d8c6aed1322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adaptable
• Version Model Number: Adaptable Rail Extender
• Catalog Number: 804-33-006
• Company DUNS: 036253884
• Company Name: Quantum Ops, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012987818 [Primary]

FDA Product Code

• BWN: Table And Attachments, Operating-Room

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-10
• Device Publish Date: 2025-06-02

Devices Manufactured by Quantum Ops, Inc.

• 00860012987818 - Adaptable: 2025-06-10The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by extending the Rail of the Back Side of the T-Max to install the Adaptable Arm, achieving a complete exposure and mobility on the patient arm.
• 00860012987818 - Adaptable: 2025-06-10 The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by exte
• 00860012987825 - Stryker: 2025-02-20
• 00860012987801 - Arvis: 2024-11-20