AccessGUDID - DEVICE: Atopavo (00860003521205)

GUDID

Device Identifier (DI) Information

Brand Name: Atopavo
Version or Model: 102-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ONPACE PHARMA LLC

Primary DI Number: 00860003521205
Issuing Agency: GS1
Commercial Distribution End Date: July 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081039213 *Terms of Use

Device Description: Atopavo is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, Atopavo provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

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?
58133	Skin osmotic dressing, non-antimicrobial	A substance (e.g., ointment, cream, spray, impregnated material) intended to be topically applied to the skin (e.g., face, eyelids, extremities) and containing compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to expedite wound healing and skin re-epithelialization primarily through osmotic properties which absorb and retain water to create a moist environment; it does not include antimicrobial agents. It may be used to treat superficial and/or deep wounds (e.g., abrasions, lacerations, burns, surgical wounds, decubitus sores, ulcers). 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
Special Storage Condition, Specify: Store at room temperature, do not freeze.

Clinically Relevant Size

[?]

Size Type Text
Weight: 45 Gram

Device Record Status

Public Device Record Key: 11d8e780-a053-4781-8823-d14646949510
Public Version Date: November 09, 2022
Public Version Number: 2
DI Record Publish Date: June 25, 2020