FDA.report

Dermapure

Primary DI
00850004779484
Brand
Dermapure
Company
SAFE N' SIMPLE LLC
Model
SNS51118
Catalog number
SNS51118
Device description
Dermapure Wound Cleanser 8 ounce Bottle
Published
2019-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850004779484PrimaryGS10
00850004779477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004779484008500047794848500047794840850004779484
00850004779477008500047794778500047794770850004779477

GMDN Terms

TermDefinition
Wound irrigation solution, non-sterileA non-sterile 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 normally available [non-prescription] over-the-counter (OTC) for home-use. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Total Volume8Fluid Ounce

Sterilization Methods

Method

Contacts

PhoneEmail
2482144877amy@sns-medical.com

Regulatory Flags

DUNS number
807812412
Device count
8
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00810040134401SimpuritySNS58825SNS588252025-06-17
00810040135750SimpuritySNS74816SNS748162025-06-17
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00810040135828SimpuritySNS58318SNS583182025-06-17
00810040135842SimpuritySNS58336SNS583362025-06-17
00810040135866SimpuritySNS54410SNS544102025-06-17
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00810040135903SimpuritySNS54046SNS540462025-06-17
00810040135927SimpuritySNS54414SNS544142025-06-17
00810040135941SimpuritySNS52245SNS522452025-06-17
00810040135965SimpuritySNS52044SNS520442025-06-17
00810040135989SimpuritySNS52045SNS520452025-06-17
00810040136009SimpuritySNS52036SNS520362025-06-17

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