exofin High Viscosity Tissue Adhesive EX70407

GUDID 00854137001146

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 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 ID00854137001146
NIH Device Record Key29eee607-3a3e-4cf8-a52b-b1361d447bd5
Commercial Distribution StatusIn Commercial Distribution
Brand Nameexofin High Viscosity Tissue Adhesive
Version Model NumberEX70407
Catalog NumberEX70407
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@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com
Phone844-633-6583
Emailcustomerservice@chemencemedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100854137001146 [Primary]
GS100854137001221 [Package]
Package: Inner Pack [10 Units]
In Commercial Distribution
GS103085413700147 [Package]
Contains: 20854137001147
Package: Case [6 Units]
Discontinued: 2018-06-01
Not in Commercial Distribution
GS110854137001228 [Package]
Contains: 00854137001221
Package: Case [60 Units]
In Commercial Distribution
GS120854137001140 [Package]
Package: Box [6 Units]
In Commercial Distribution
GS120854137001147 [Package]
Package: Box [6 Units]
In Commercial Distribution
GS130854137001147 [Package]
Contains: 20854137001147
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 Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

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00854137001726 - GluGone Adhesive Remover, 4 oz.2022-07-05 4 OZ
10854137001730 - GluGone Adhesive Remover, 0.67 oz.2022-07-05 0.67 OZ
00854137001740 - LiquidSkin, 0.5g2022-07-05

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