FDA.reportPublic FDA data

BioSentry™ Tract Sealant System

Primary DI
10848782023148
Brand
BioSentry™ Tract Sealant System
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
768022019S
Device description
BioSentry™ Tract Sealant System
Published
2016-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMTAbsorbable lung biopsy plug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMTAbsorbable Lung Biopsy PlugGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN090007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN090007000BIO-SEAL LUNG BIOPSY TRACT SYSTEMAngiotech2012-12-19OMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782023148PackageGS15In Commercial Distribution
00848782023141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878202314810848782023148
00848782023141008487820231418487820231410848782023141

GMDN Terms#

Term, Definition table
TermDefinition
Lung biopsy procedure kitA collection of sterile devices designed to perform a histologic specimen aspiration during a percutaneous lung biopsy. It typically includes a biopsy needle and other supplies to perform this procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags#

DUNS number
812762226
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848782006021OnatecOB112210OB1122102022-04-26
00848782006038OnatecOB211830OB2118302022-04-26
00848782006045OnatecOB211845OB2118452022-04-26
00848782006052OnatecOB311345OB3113452022-04-26
00848782006069OnatecOB341902OB3419022022-04-26
00848782006076OnatecOB341920OB3419202022-04-26
00848782006083OnatecOB341925OB3419252022-04-26
00848782006090OnatecOB351102OB3511022022-04-26
00848782006106OnatecOB351345OB3513452022-04-26
00848782006113OnatecOB418535OB4185352022-04-26
00848782006120OnatecOB418545OB4185452022-04-26
00848782006137OnatecOB468055OB4680552022-04-26
00848782006144OnatecOB468530OB4685302022-04-26
00848782006151OnatecOB468535OB4685352022-04-26
00848782006168OnatecOB468545OB4685452022-04-26
00848782006175OnatecOB468555OB4685552022-04-26
00848782006182OnatecOB498545OB4985452022-04-26
00848782008421"C22 5-0 Grn Brd Pvn 18""/45cm"1176B11762015-10-20
00848782008438"C6 4-0 Grn Brd Pvn 18""/45cm"1180B11802015-10-20
00848782008445"C6 4-0 Wht Brd Pvn 18""/45cm"1205B12052015-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450808122BioSentry®Merit Medical Systems, Inc.OMT2024-03-14
00848782023141BioSentry™ Tract Sealant SystemSurgical Specialties México, S. de R.L. de C.V.OMT2016-02-16