AccessGUDID - DEVICE: GlucanPro 3000 (00855638007064)

GUDID

Device Identifier (DI) Information

Brand Name: GlucanPro 3000
Version or Model: GPC3-0180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GPC3-0180
Company Name: STELLEN MEDICAL, LLC

Primary DI Number: 00855638007064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801160037 *Terms of Use

Device Description: GlucanPro Cream is intended to be used as an aid in the management of superficial abrasions, scrapes, cuts and lacerations; minor burns and scalds, partial and full thickness wounds, and irritations of the skin. GlucanPro Cream may also be used, under the supervision/direction of a health care professional for pressure ulcers; venous, diabetic, and arterial ulcers; partial thickness burns; donor graft sites; and surgical wounds. GlucanPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

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):	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?
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
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002077	000

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
Total Volume: 18 Fluid Ounce

Device Record Status

Public Device Record Key: c2026c70-d460-4fa9-852d-3fc1f4c9d49e
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: October 22, 2020