derma+flex QS QS70806

GUDID 00854137001177

Tissue Adhesive with Dauber/Nozzle

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
Primary Device ID00854137001177
NIH Device Record Keye24b952d-2102-4947-95c9-7faed11257ba
Commercial Distribution StatusIn Commercial Distribution
Brand Namederma+flex QS
Version Model NumberQS70806
Catalog NumberQS70806
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854137001177 [Primary]
GS110854137001174 [Package]
Package: Box [6 Units]
In Commercial Distribution
GS120854137001171 [Package]
Contains: 10854137001174
Package: Case [6 Units]
In Commercial Distribution
GS130854137001178 [Package]
Package: Box [6 Units]
In Commercial Distribution
GS140854137001175 [Package]
Contains: 30854137001178
Package: Case [10 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

On-Brand Devices [derma+flex QS]

00854137001177Tissue Adhesive with Dauber/Nozzle
00854137001160Topical Tissue Adhesive with Flat Tip

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