exofin MICRO High Viscosity Tissue Adhesive EX70405

GUDID 00854137001153

Topical Tissue Adhesive

CHEMENCE MEDICAL PRODUCTS, INC.

Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive
Primary Device ID00854137001153
NIH Device Record Keyba82f36f-d4a7-4191-8fe5-0a313d7b92ea
Commercial Distribution StatusIn Commercial Distribution
Brand Nameexofin MICRO High Viscosity Tissue Adhesive
Version Model NumberEX70405
Catalog NumberEX70405
Company DUNS079163089
Company NameCHEMENCE MEDICAL PRODUCTS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com
Phone844-633-6583
Emailcustomerservice@chemence.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854137001153 [Primary]
GS100854137001252 [Package]
Package: Inner Pack [10 Units]
In Commercial Distribution
GS110854137001150 [Package]
Package: Box [6 Units]
In Commercial Distribution
GS110854137001259 [Package]
Contains: 00854137001252
Package: Case [60 Units]
In Commercial Distribution
GS120854137001157 [Package]
Contains: 10854137001150
Package: Case [6 Units]
In Commercial Distribution
GS130854137001154 [Package]
Package: Inner Pack [10 Units]
In Commercial Distribution
GS140854137001151 [Package]
Contains: 30854137001154
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPNTissue Adhesive For The Topical Approximation Of Skin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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