AccessGUDID - DEVICE: PureLife+ Cotton Tip Applicators (D79011132021)

GUDID

Device Identifier (DI) Information

Brand Name: PureLife+ Cotton Tip Applicators
Version or Model: 1113202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1113202
Company Name: PURELIFE, LLC

Primary DI Number: D79011132021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: PureLife+ Cotton Tip Applicators, 6", Non-sterile cotton tip applicators, Available in 3" or 6"

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?
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / sponge,nonresorbable for external use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e210b818-73a0-4a1e-8f0e-ef8dec531571
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023