AccessGUDID - DEVICE: AcanthusTM (00860010482643)

GUDID

Device Identifier (DI) Information

Brand Name: AcanthusTM
Version or Model: NBP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NBP
Company Name: Acanthus Medical Creations LLC

Primary DI Number: 00860010482643
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2023
Device Count: 60
Labeler D-U-N-S® Number*: 065124205 *Terms of Use

Device Description: Acanthus Nasal Bridge Protector (Bag of 60)

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):	Yes
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?
58749	Dressing-fixation skin adhesive tape, silicone	A long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: ca21f822-652c-4ee6-905f-a641c568ff9c
Public Version Date: August 03, 2023
Public Version Number: 2
DI Record Publish Date: June 05, 2023