ExSept Plus 15117

GUDID 20898021000079

Skin and wound cleanser.

ANGELINI PHARMA INC.

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile
Primary Device ID20898021000079
NIH Device Record Keya8001e7b-3f39-43c9-a4e9-2250e6b28322
Commercial Distribution StatusIn Commercial Distribution
Brand NameExSept Plus
Version Model Number500 mL
Catalog Number15117
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

Customer Support Contacts

Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com
Phone1-800-726-2308
Emailcustomerservice@angelini-us.com

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
GS100898021000075 [Primary]
GS100898021000075 [Primary]
GS100898021000075 [Primary]
GS120898021000079 [Package]
Contains: 00898021000075
Package: case [12 Units]
In Commercial Distribution
GS120898021000079 [Package]
Contains: 00898021000075
Package: case [12 Units]
In Commercial Distribution
GS120898021000079 [Package]
Contains: 00898021000075
Package: case [12 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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