Simpurity SNS58825

GUDID 00810040134401

Simpurity Hydrogel Wound Filler in a 25g Tube

SAFE N' SIMPLE LLC

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00810040134401
NIH Device Record Keyd526f4bf-f49f-48d9-bfb4-6f4a3b170617
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpurity
Version Model NumberSNS58825
Catalog NumberSNS58825
Company DUNS807812412
Company NameSAFE N' SIMPLE LLC
Device Count240
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810040134401 [Unit of Use]
GS100810040134692 [Primary]
GS100810040134708 [Primary]

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-25
Device Publish Date2025-06-17