BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Primocyn Eau Divine Skin Hydrogel

DI: 00850015491214 · Model: 86004 · Sonoma Pharmaceuticals, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: Primocyn Eau Divine Skin Hydrogel
Primary DI: 00850015491214
Version / Model: 86004
Catalog Number: 86004
Company Name: Sonoma Pharmaceuticals, Inc.
Labeler DUNS: 081642964
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-12-02
Public Version: 1
Public Version Date: 2022-12-12
Public Version Status: New
Public Device Record Key: e7b1f060-24ab-48a6-a270-4e8bb34807d0

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: Yes
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850015491214	GS1
Package	20850015491218	GS1	Box	12	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Weight	50	Gram