HemaDerm

Basic Information

• Brand Name: HemaDerm
• Primary DI: 00801741044083
• Version / Model: ENT0001-2
• Catalog Number: ENT0001-2
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-09
• Public Version: 1
• Public Version Date: 2023-10-17
• Public Version Status: New
• Public Device Record Key: a3d80ec3-90cb-4da2-ad1f-d4d7fda20223

Device Description

ENT Kit with HemaDerm Topical Hemostat

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHB	POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE	Ear, Nose, Throat	874.3620	2
QSY	Hemostatic wound dressing without thrombin or other biologics	Unknown		U
LYA	SPLINT, INTRANASAL SEPTAL	Ear, Nose, Throat	874.4780	1

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	10801741044080	GS1	CA	5	In Commercial Distribution
Primary	00801741044083	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033666	000

Device Sizes

Type	Value	Unit	Text
Weight	2	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 140 Degrees Fahrenheit