AccessGUDID - DEVICE: DeScribe Transparent PFD Patch (00864525000200)

GUDID

Device Identifier (DI) Information

Brand Name: DeScribe Transparent PFD Patch
Version or Model: PFD-462
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: On Light Sciences, Inc.

Primary DI Number: 00864525000200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030833535 *Terms of Use

Device Description: Individually packaged DeScribe PFD Patch (each)

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):	Yes
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?
58300	Synthetic polymer semi-permeable film dressing, adhesive, non-sterile	A non-sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to skin typically intended to fix a primary dressing or a medical device (e.g. drainage tube), or to provide protection from fluids. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PKO	Transparent Patch For Use In Treatment Of Tattoos

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48138b39-43cd-4c44-b44c-75bb61841a4f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016