PrimaDerm® DUP69201

GUDID 30381780491860

PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 16 fl oz bottle.

Derma Sciences Canada Inc

Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile Non-antimicrobial wound irrigation solution, multiple solute, non-sterile
Primary Device ID30381780491860
NIH Device Record Key21d436d4-a639-4811-abd4-ad542f034e3e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimaDerm®
Version Model Number69201
Catalog NumberDUP69201
Company DUNS200564891
Company NameDerma Sciences Canada Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780491866 [Primary]
GS110381780491866 [Primary]
GS110381780491866 [Primary]
GS130381780491860 [Package]
Contains: 10381780491866
Package: Case [12 Units]
In Commercial Distribution
GS130381780491860 [Package]
Contains: 10381780491866
Package: Case [12 Units]
In Commercial Distribution
GS130381780491860 [Package]
Contains: 10381780491866
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

MGPDRESSING, WOUND AND BURN, OCCLUSIVE
MGPDRESSING, WOUND AND BURN, OCCLUSIVE
MGPDRESSING, WOUND AND BURN, OCCLUSIVE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2018-10-23

On-Brand Devices [PrimaDerm®]

30381780491877PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 4 fl oz bottle.
30381780491860PrimaDerm Wound Cleanser (Preserved). Non-Cytotoxic, No Rinse Formualtion. 16 fl oz bottle.

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