AccessGUDID - DEVICE: Dermaso Plus Cream (00860010890738)

GUDID

Device Identifier (DI) Information

Brand Name: Dermaso Plus Cream
Version or Model: 073-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aletris Pharmaceuticals, LLC

Primary DI Number: 00860010890738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118956541 *Terms of Use

Device Description: Indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dermaso Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

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:	Yes
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?
46206	Dry skin moisture barrier dressing	A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 450 Gram

Device Record Status

Public Device Record Key: d408175a-1c9e-4946-b466-75ad67295db3
Public Version Date: May 08, 2024
Public Version Number: 1
DI Record Publish Date: April 30, 2024