StabilICE 900218

GUDID 00850027837659

StabilICE

ACUTUS MEDICAL, INC.

Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: 00850027837659
• NIH Device Record Key: 1d9a7541-238b-4ab0-833a-b6a59f3d28b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StabilICE
• Version Model Number: 900218
• Catalog Number: 900218
• Company DUNS: 844418199
• Company Name: ACUTUS MEDICAL, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027837529 [Previous]
GS1	00850027837659 [Primary]

FDA Product Code

• HYA: Forceps, Wire Holding

Sterilization

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

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

[00850027837659]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-01

On-Brand Devices [StabilICE]

• 00850027837529: StabilICE
• 00850027837659: StabilICE
• 00850027837642: StabilICE