Octylbond M1201

GUDID 20854137001195

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
Primary Device ID20854137001195
NIH Device Record Key3c236c4b-3a37-41f0-bd66-1d12925de7a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctylbond
Version Model NumberM1201
Catalog NumberM1201
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854137001191 [Primary]
GS110854137001198 [Package]
Contains: 00854137001191
Package: Box [6 Units]
In Commercial Distribution
GS120854137001195 [Package]
Contains: 10854137001198
Package: 6 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-18

Devices Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.

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
00854137001740 - LiquidSkin, 0.5g2022-07-05

Trademark Results [Octylbond]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OCTYLBOND
OCTYLBOND
85867075 4512311 Live/Registered
Chemence Medical Products, Inc
2013-03-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.