BioSentry™ Tract Sealant System

GUDID 10848782023148

BioSentry™ Tract Sealant System

Surgical Specialties México, S. de R.L. de C.V.

Lung biopsy procedure kit
Primary Device ID10848782023148
NIH Device Record Keyc6b37d47-f7ce-4110-8ee4-c8f039d17a46
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioSentry™ Tract Sealant System
Version Model Number768022019S
Company DUNS812762226
Company NameSurgical Specialties México, S. de R.L. de C.V.
Device Count1
DM Exempttrue
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

Phone+1(877)991-1110
Emailservice@surgicalspecialties.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848782023141 [Primary]
GS110848782023148 [Package]
Contains: 00848782023141
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMTAbsorbable lung biopsy plug

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 Date2016-02-16

Devices Manufactured by Surgical Specialties México, S. de R.L. de C.V.

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20705031227993 - Stratafix Spiral2023-12-25 CT-1 0 MONODERM 45CM
20705031228006 - Stratafix Spiral2023-12-25 PS-2 3-0 MONODERM 60CM
20705031228013 - Stratafix Spiral2023-12-25 PS-2 2-0 MONODERM 30CM
20705031228020 - Stratafix Spiral2023-12-25 CT-1 1 MONODERM 45CM
20705031228037 - Stratafix Spiral2023-12-25 SH 0 MONODERM 20CM
20705031228044 - Stratafix Spiral2023-12-25 PS-1 2-0 MONODERM 30CM

Trademark Results [BioSentry]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOSENTRY
BIOSENTRY
86220179 4843730 Live/Registered
Biosentry, Inc.
2014-03-13
BIOSENTRY
BIOSENTRY
85808191 4544384 Live/Registered
ANGIOTECH PHARMACEUTICALS (US), INC.
2012-12-20
BIOSENTRY
BIOSENTRY
78464175 3027660 Dead/Cancelled
JMAR, LLC
2004-08-09
BIOSENTRY
BIOSENTRY
76229337 not registered Dead/Abandoned
BIOCENTRIC SOLUTIONS, INC.
2001-03-23
BIOSENTRY
BIOSENTRY
74224769 1732370 Dead/Cancelled
BIOSENTRY, INC.
1991-11-25

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