Chito-SAM™ 100

GUDID 10822045000022

CHITOSAM 100, 4IN X 4IN

SAM Medical Products

Chitosan haemostatic agent, professional

• Primary Device ID: 10822045000022
• NIH Device Record Key: fba50073-43e9-473b-846d-39297abbe18e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chito-SAM™ 100
• Version Model Number: CT100-A-EN
• Company DUNS: 131084188
• Company Name: SAM Medical Products
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com
• Phone: 5036395474
• Email: raqa@sammedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822045000025 [Primary]
GS1	10822045000022 [Package]; Contains: 00822045000025; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133121

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [Chito-SAM™ 100]

• 10822045000336: CHITOSAM 100, 3IN X 4FT
• 10822045000022: CHITOSAM 100, 4IN X 4IN
• 10822045000008: CHITOSAM 100, 3IN X 6FT