Surgi-Plus 68-6201-B

GUDID 04895237102124

PE Film Gown

KENPAX INTERNATIONAL LIMITED

Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use

• Primary Device ID: 04895237102124
• NIH Device Record Key: 5ad41a22-6df7-497c-be25-524a53e6d877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgi-Plus
• Version Model Number: 1
• Catalog Number: 68-6201-B
• Company DUNS: 686206765
• Company Name: KENPAX INTERNATIONAL LIMITED
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04895237102117 [Package]; Package: case [1 Units]; In Commercial Distribution
GS1	04895237102124 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [Surgi-Plus]

• 04895237100137: Procedure Mask
• 74895237109122: Surgical Mask
• 04895237102124: PE Film Gown
• 84895237109112: The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel fr
• 84895237106036: PE Film Gown
• 74895237106015: PE Film Gown