exofin SC

GUDID 00854137001979

exofin® SC High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is supplied in collapsible aluminum tube with two nozzle applicator tips packaged in a sealed Tyvek pouch.

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
Primary Device ID00854137001979
NIH Device Record Key538bbeb5-0b31-41a1-86b9-647ccce9d9b2
Commercial Distribution StatusIn Commercial Distribution
Brand Nameexofin SC
Version Model NumberEXSC5G
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com
Phone18446334583
Emailcustomerservice@chemence.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854137001979 [Primary]
GS110854137001976 [Package]
Package: Carton [6 Units]
In Commercial Distribution

FDA Product Code

MPNTissue Adhesive For The Topical Approximation Of Skin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-28
Device Publish Date2024-06-20

Devices Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.

00854137001979 - exofin SC2024-06-28exofin® SC High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is supplied in collapsible aluminum tube with two nozzle applicator tips packaged in a sealed Tyvek pouch.
00854137001979 - exofin SC2024-06-28 exofin® SC High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacryl
00854137001665 - LiquidSkin, 1.0g2022-07-05
00854137001689 - exofin Mastic, 2 oz. 2022-07-05 Class 1
00854137001696 - exofin Mastic, 0.67ml2022-07-05 Class 1
00854137001702 - exofin Mastic, 1 oz. 2022-07-05 Class 1
00854137001719 - GluGone Adhesive Remover, 2 oz.2022-07-05 Glugone 2 oz
00854137001726 - GluGone Adhesive Remover, 4 oz.2022-07-05 4 OZ
10854137001730 - GluGone Adhesive Remover, 0.67 oz.2022-07-05 0.67 OZ

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