Exofin XL

GUDID 00854137001481

Topical Tissue Adhesive

CHEMENCE MEDICAL PRODUCTS, INC.

Skin-approximation adhesive
Primary Device ID00854137001481
NIH Device Record Key3caaa203-d34e-4cb8-88f8-7b76bf225cef
Commercial Distribution StatusIn Commercial Distribution
Brand NameExofin XL
Version Model NumberEX72006
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854137001474 [Primary]
GS100854137001481 [Package]
Contains: 00854137001474
Package: Box [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-07
Device Publish Date2019-05-30

Devices Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.

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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
00854137001740 - LiquidSkin, 0.5g2022-07-05

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