Sealk

GUDID 10850744001361

Sealk Hemostatic Dressing for ENT ,Neck%Head, thyroid 1"X3"(2.5cmX7.5cm) 10/per box

Lifescience Plus, Inc.

Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

• Primary Device ID: 10850744001361
• NIH Device Record Key: 9ce0a5d2-04fa-49a5-9815-b8a54c71574c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sealk
• Version Model Number: SK-iX-34
• Company DUNS: 190600051
• Company Name: Lifescience Plus, Inc.
• Device Count: 10
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850744001364 [Primary]
GS1	10850744001361 [Unit of Use]

FDA Product Code

• QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [Sealk]

• 00850744001371: Sealk Hemostatic Dressing 1”x2” (2.5cmx5cm) 10/box
• 10850744001361: Sealk Hemostatic Dressing for ENT ,Neck%Head, thyroid 1"X3"(2.5cmX7.5cm) 10/per box
• 00850744001302: Sealk Hemostatic Dressing for nose,thyroid 2"X3"(5cmX7cm) 10/box