Custom Healthcare Systems, Inc.

GUDID 20811870035931

CUSTOM HEALTHCARE SYSTEMS, INC.

Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit Surgical patient preparation kit

• Primary Device ID: 20811870035931
• NIH Device Record Key: 40744808-73dd-4696-9a90-f87a4c074ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Healthcare Systems, Inc.
• Version Model Number: B9-19835
• Company DUNS: 175254820
• Company Name: CUSTOM HEALTHCARE SYSTEMS, 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811870035937 [Primary]
GS1	20811870035931 [Package]; Contains: 00811870035937; Package: NA [10 Units]; In Commercial Distribution

FDA Product Code

• LRP: Tray, Surgical

Sterilization

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

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

[20811870035931]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-10-13

On-Brand Devices [Custom Healthcare Systems, Inc.]

• 20811870036310: R1554
• 20811870036341: B9-16938A
• 20811870036396: KM3405353-2
• 20811870035931: B9-19835
• 20811870035368: D21-9064
• 20811870036235: B9-15934C