PerClot PCET038

GUDID 05413765891397

PerClot 38cm Laparoscopic Tip

BAXTER HEALTHCARE CORPORATION

Plant polysaccharide haemostatic agent, bioabsorbable

• Primary Device ID: 05413765891397
• NIH Device Record Key: 1dfbd82d-05c0-493b-8a26-3cf4567633e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerClot
• Version Model Number: PCET038
• Catalog Number: PCET038
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com
• Phone: +1(800)422-9837
• Email: US-MEDINFO_MEDPRODUCTS@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765891397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210036

FDA Product Code

• LMG: Agent, absorbable hemostatic, non-collagen based

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: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [PerClot]

• 05413765891397: PerClot 38cm Laparoscopic Tip
• 75413765891389: PerClot 20cm Extender Tip
• 05413765891373: PerClot 5g - 9cm Standard Tip
• 05413765891366: PerClot 3g - 9cm Standard Tip
• 05413765891335: PerClot 1g - 9cm Standard Tip