Custom Healthcare Systems, Inc.

GUDID 20811870036341

CUSTOM HEALTHCARE SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 20811870036341
• NIH Device Record Key: 1775459c-4a77-4192-b0c0-7b376d2f2153
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Healthcare Systems, Inc.
• Version Model Number: B9-16938A
• 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	00811870036347 [Primary]
GS1	20811870036341 [Package]; Contains: 00811870036347; Package: NA [12 Units]; In Commercial Distribution

FDA Product Code

• LRO: General Surgery Tray

Sterilization

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

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

[20811870036341]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-22
• Device Publish Date: 2020-09-14

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

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