Hydrozid

Basic Information

• Brand Name: Hydrozid
• Primary DI: 05744002420033
• Version / Model: 101
• Company Name: Bibawo Medical A/S
• Labeler DUNS: 306164504
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 1
• Public Version Date: 2023-06-21
• Public Version Status: New
• Public Device Record Key: c60d380b-4686-4bfa-9402-733b550189e2

Device Description

Hydrozid, portable cryosurgery device, 200mL

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44724	Cryogenic spray, cutaneous	A refrigerant (e.g., dimethyl ether and propane) typically contained in an aerosol dispenser and intended to be used to freeze superficial skin lesions (e.g., warts) for their destruction and removal. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05744002420033	GS1

Premarket Submissions

Submission Number	Supplement Number
K201740	000

Device Sizes

Type	Value	Unit	Text
Total Volume	200	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: store upright
• Type: Special Storage Condition, Specify
• Special Conditions: Store out of direct sunlight