Skin Affix

GUDID 00897392000240

Topic Skin Adhesive - Skin Affix .4ml

SOURCEMARK, LLC.

Skin-approximation adhesive
Primary Device ID00897392000240
NIH Device Record Key857dfa92-6eb4-497c-acd0-f88e6621e0fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkin Affix
Version Model NumberM1204
Company DUNS121225812
Company NameSOURCEMARK, LLC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com
Phone615-269-6010
Emailcustomerservice@sourceMarkusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100897392000226 [Primary]
GS100897392000233 [Package]
Contains: 00897392000226
Package: Carton [12 Units]
In Commercial Distribution
GS100897392000240 [Package]
Contains: 00897392000233
Package: Shipper Carton [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 Date2020-07-09
Device Publish Date2016-08-16

Devices Manufactured by SOURCEMARK, LLC.

00813799002748 - SourceMark 2022-03-04
00813799002861 - SourceMark 2022-03-04
00813799002878 - SourceMark 2022-03-04
00813799003349 - SourceMark 2020-12-14
10813799003377 - SourceMark 2020-12-14
10813799003407 - SourceMark 2020-12-14
10813799003438 - SourceMark 2020-12-14
10813799003490 - SourceMark 2020-12-14

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