Custom Medical Specialties

GUDID 00815849023352

Film Reinforced XXL Gown - Sterile

CUSTOM ASSEMBLIES, INC.

Patient surgical drape, single-use, sterile

• Primary Device ID: 00815849023352
• NIH Device Record Key: d9cd4a37-9b68-40c5-a089-54b56f40d2f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom Medical Specialties
• Version Model Number: CMS-6013
• Company DUNS: 948904735
• Company Name: CUSTOM ASSEMBLIES, 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: 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	00815849023345 [Primary]
GS1	00815849023352 [Package]; Contains: 00815849023345; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Custom Medical Specialties]

• 00815849023055: 72" Drainage Hose - Sterile
• 00815849023277: Large Bore Infiltration Set - Sterile
• 00815849023291: 20" LS Extension Set - Sterile
• 00815849023352: Film Reinforced XXL Gown - Sterile