AccessGUDID - DEVICE: MolecuLightDX DarkDrape (00628110259394)

GUDID

Device Identifier (DI) Information

Brand Name: MolecuLightDX DarkDrape
Version or Model: 1973
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MolecuLight Inc

Primary DI Number: 00628110259394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202822052 *Terms of Use

Device Description: Drapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX.

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):	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?
47783	Patient surgical drape, single-use	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, Surgical, Exempt

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: 46999456-54d3-4d97-892e-0ec94030a5a1
Public Version Date: January 13, 2022
Public Version Number: 1
DI Record Publish Date: January 05, 2022