Custom Assemblies, Inc.

GUDID 00815849023437

Procedure Kit

CUSTOM ASSEMBLIES, INC.

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

• Primary Device ID: 00815849023437
• NIH Device Record Key: 123dc72a-fc4a-4c22-b6b5-f6741960efa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Assemblies, Inc.
• Version Model Number: CMS-2012-R3
• Company DUNS: 948904735
• Company Name: CUSTOM ASSEMBLIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815849023437 [Primary]

FDA Product Code

• LRO: General Surgery Tray

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: 2023-09-21
• Device Publish Date: 2023-09-13

On-Brand Devices [Custom Assemblies, Inc. ]

• 00815849023444: Procedure Kit
• 00815849023437: Procedure Kit