Hysolate

Basic Information

• Brand Name: Hysolate
• Primary DI: 07630392900324
• Version / Model: 60031354
• Company Name: Dent4You AG
• Labeler DUNS: 480152811
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2022-08-22
• Public Version: 2
• Public Version Date: 2024-01-04
• Public Version Status: Update
• Public Device Record Key: 82e2d1f5-b024-4f0b-8fb7-47e66892704b

Device Description

Latex DD Black pre-printed x-heavy Adult (6x6), 36 pcs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
EIE	Dam, Rubber	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11155	Rubber dam, Hevea-latex	A sheet of elastomeric material made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630392900324	GS1
Unit of Use	17630392900321	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 26 Degrees Celsius