PRO3DURE IS-1.1

Basic Information

• Brand Name: PRO3DURE IS-1.1
• Primary DI: EPRCA0010100
• Version / Model: 8 double cartridges of 2 x 25 ml
• Company Name: pro3dure medical GmbH
• Labeler DUNS: 312947842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-17
• Public Version: 2
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 0db86d5f-abc5-40a0-8a7e-0e8ef2aa3703

Device Description

IS-1.1 - 8 double cartridges of 2 x 25 ml

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LDG	Kit, Earmold, Impression	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44974	Earmould impression material	A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EPRCA0010100	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight