AccessGUDID - DEVICE: MPM CoolMagic (00366977206334)

GUDID

Device Identifier (DI) Information

Brand Name: MPM CoolMagic
Version or Model: 3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MP00206
Company Name: Mpm Medical, LLC

Primary DI Number: 00366977206334
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081241522 *Terms of Use

Device Description: MPM CoolMagic Clear Hydogel Sheet Wound Drsg 3.75X3.75. Package configuration: 10 Dressings. Per sbs; 3 sbs per case.

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):	No
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?
59102	Genital inflammation/infection hydrogel dressing	A gel intended to be applied to the skin or mucosa to treat inflammation/infection of the external genitalia (e.g., vulvitis and balanitis) through hydration and infection control properties (e.g., microbial binding, persistent barrier to help prevent secondary infection). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: adbe388e-dc19-4afd-9cf4-6b54935cfe43
Public Version Date: February 24, 2025
Public Version Number: 2
DI Record Publish Date: December 07, 2022