Primary Device ID | 10848782023148 |
NIH Device Record Key | c6b37d47-f7ce-4110-8ee4-c8f039d17a46 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BioSentry™ Tract Sealant System |
Version Model Number | 768022019S |
Company DUNS | 812762226 |
Company Name | Surgical Specialties México, S. de R.L. de C.V. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(877)991-1110 |
service@surgicalspecialties.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848782023141 [Primary] |
GS1 | 10848782023148 [Package] Contains: 00848782023141 Package: Box [5 Units] In Commercial Distribution |
OMT | Absorbable lung biopsy plug |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-02-16 |
20705031227634 - Stratafix Spiral | 2023-12-25 PS-2 2-0 MONODERM 60CM |
20705031227986 - Stratafix Spiral | 2023-12-25 PS-2 3-0 MONODERM 30CM |
20705031227993 - Stratafix Spiral | 2023-12-25 CT-1 0 MONODERM 45CM |
20705031228006 - Stratafix Spiral | 2023-12-25 PS-2 3-0 MONODERM 60CM |
20705031228013 - Stratafix Spiral | 2023-12-25 PS-2 2-0 MONODERM 30CM |
20705031228020 - Stratafix Spiral | 2023-12-25 CT-1 1 MONODERM 45CM |
20705031228037 - Stratafix Spiral | 2023-12-25 SH 0 MONODERM 20CM |
20705031228044 - Stratafix Spiral | 2023-12-25 PS-1 2-0 MONODERM 30CM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIOSENTRY 86220179 4843730 Live/Registered |
Biosentry, Inc. 2014-03-13 |
BIOSENTRY 85808191 4544384 Live/Registered |
ANGIOTECH PHARMACEUTICALS (US), INC. 2012-12-20 |
BIOSENTRY 78464175 3027660 Dead/Cancelled |
JMAR, LLC 2004-08-09 |
BIOSENTRY 76229337 not registered Dead/Abandoned |
BIOCENTRIC SOLUTIONS, INC. 2001-03-23 |
BIOSENTRY 74224769 1732370 Dead/Cancelled |
BIOSENTRY, INC. 1991-11-25 |