ExSept Plus 15104

GUDID 20898021000109

Skin and would cleanser.

ANGELINI PHARMA INC.

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile
Primary Device ID20898021000109
NIH Device Record Keydc6998fe-8660-4a3c-98ad-68fe9fa13db7
Commercial Distribution StatusIn Commercial Distribution
Brand NameExSept Plus
Version Model Number100 mL
Catalog Number15104
Company DUNS078843940
Company NameANGELINI PHARMA 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store upright in original container.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sun light.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright in original container.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sun light.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright in original container.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sun light.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100898021000105 [Primary]
GS100898021000105 [Primary]
GS100898021000105 [Primary]
GS120898021000109 [Package]
Contains: 00898021000105
Package: Case [24 Units]
In Commercial Distribution
GS120898021000109 [Package]
Contains: 00898021000105
Package: Case [24 Units]
In Commercial Distribution
GS120898021000109 [Package]
Contains: 00898021000105
Package: Case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FQHLavage, Jet
FQHLavage, Jet
FQHLavage, Jet

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2016-08-29

On-Brand Devices [ExSept Plus]

20898021000109Skin and would cleanser.
00898021000099Skin and wound cleanser.
00898021000082Skin and wound cleanser.
20898021000079Skin and wound cleanser.

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