AccessGUDID - DEVICE: Reso-Pac Hydrophilic Periodontal Dressing (D2481550200)

GUDID

Device Identifier (DI) Information

Brand Name: Reso-Pac Hydrophilic Periodontal Dressing
Version or Model: 155020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 155020
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: D2481550200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 1 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 Gram Cups

Device Record Status

Public Device Record Key: 1241ca4b-f826-4e5d-b525-1494aabd192c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016