AccessGUDID - DEVICE: PrimaDerm® (10381780491873)

GUDID

Device Identifier (DI) Information

Brand Name: PrimaDerm®
Version or Model: 69202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DUP69202
Company Name: Derma Sciences Canada Inc

Primary DI Number: 10381780491873
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 4 fl oz bottle.

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:	No
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?
58931	Non-antimicrobial wound irrigation solution, multiple solute	A solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGP	DRESSING, WOUND AND BURN, OCCLUSIVE

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4.15 oz
Device Size Text, specify: 118 ml

Device Record Status

Public Device Record Key: 4e14adb0-d6d0-4117-9418-88b869c7f07d
Public Version Date: June 25, 2024
Public Version Number: 4
DI Record Publish Date: October 23, 2018