Reso-Pac Hydrophilic Periodontal Dressing

Basic Information

• Brand Name: Reso-Pac Hydrophilic Periodontal Dressing
• Primary DI: D2481550200
• Version / Model: 155020
• Catalog Number: 155020
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1241ca4b-f826-4e5d-b525-1494aabd192c

Device Description

Reso-Pac Hydrophilic Periodontal Dressing (1000 x 2g Single-Use Cups)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38770	Dental pulp-capping material	A dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D2481550200	HIBCC
Unit of Use	D2481550201	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 Gram Cups

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 77 Degrees Fahrenheit