AccessGUDID - DEVICE: PureLife Dental (D79011901031)

GUDID

Device Identifier (DI) Information

Brand Name: PureLife Dental
Version or Model: 1190103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1190103
Company Name: PURELIFE, LLC

Primary DI Number: D79011901031
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: 3 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink

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":	Yes
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?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3-1/2" X 5-1/4"

Device Record Status

Public Device Record Key: c7ba474c-a630-4935-89a3-3a4f304bae35
Public Version Date: April 24, 2020
Public Version Number: 4
DI Record Publish Date: March 17, 2017