Earlens Hybrid Impression Kit

Basic Information

• Brand Name: Earlens Hybrid Impression Kit
• Primary DI: 00850013007349
• Version / Model: HIK02
• Catalog Number: HIK02
• Company Name: EARLENS CORPORATION
• Labeler DUNS: 611658795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 2
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: cde78da9-b57f-4b59-8e18-47678fdc3d4f

Device Description

Includes - Medial Impression Cartridges - Lateral Impression Cartridges - Medial Mixing Tips - Lateral Mixing Tips

Device Characteristics

• Single Use: No
• 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: Yes
• 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
LDG	Kit, Earmold, Impression	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43783	Earmould impression kit	A collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013007349	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity