EndoClot PHS

Basic Information

• Brand Name: EndoClot PHS
• Primary DI: 16972011720035
• Version / Model: EPK2305
• Catalog Number: EPK2305-01
• Company Name: EndoClot Plus Co.,Ltd.
• Labeler DUNS: 544357082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-23
• Public Version: 2
• Public Version Date: 2021-11-16
• Public Version Status: Update
• Public Device Record Key: fc663d56-fcdd-4e1e-8bfd-0e9efcd05f43

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
38771	Plant polysaccharide haemostatic agent, bioabsorbable	A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26972011720032	GS1		1	In Commercial Distribution
Primary	16972011720035	GS1