C-Sponge CSR100

GUDID D867CSR1000

Pharyngeal barrier

Xemax Surgical Products Inc

Non-woven gauze pad

• Primary Device ID: D867CSR1000
• NIH Device Record Key: b070310e-10c9-4f6d-90fb-dfdc7d250b26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Sponge
• Version Model Number: Regular
• Catalog Number: CSR100
• Company DUNS: 804495695
• Company Name: Xemax Surgical Products Inc
• Device Count: 100
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D867CSR1000 [Primary]
HIBCC	D867CSR1001 [Unit of Use]

FDA Product Code

• NAB: Gauze / Sponge,Nonresorbable For External Use

Sterilization

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

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

[D867CSR1000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-16
• Device Publish Date: 2022-08-08

On-Brand Devices [C-Sponge]

• D867CSR1000: Pharyngeal barrier
• D867CSP501: Pharyngeal barrier
• D867CSIV1001: Pharyngeal barrier
• D867CSIII001: Pharyngeal barrier
• D867CSII001: Pharyngeal barrier