SOURCE SURGICAL INC. 68-2210-W

GUDID 84895237141457

Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

KENPAX INTERNATIONAL LIMITED

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• Primary Device ID: 84895237141457
• NIH Device Record Key: 103987f0-ea60-4830-92c7-4f88e7e936a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOURCE SURGICAL INC.
• Version Model Number: 1
• Catalog Number: 68-2210-W
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	74895237141450 [Primary]
GS1	84895237141457 [Package]; Contains: 74895237141450; Package: case [1000 Units]; In Commercial Distribution

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [SOURCE SURGICAL INC.]

• 84895237141471: Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physi
• 84895237141464: Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff
• 84895237141457: Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff