BioSentry™ Tract Sealant System

Primary DI
00848782023141
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
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.

Contacts#

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

Regulatory Flags#

DUNS number
812762226
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00848782052783SharpointB934N2026-07-06
00848782052790SharpointC966N2026-07-06
00848782052806SharpointC967N2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450808122BioSentry®Merit Medical Systems, Inc.OMT2024-03-14
10848782023148BioSentry™ Tract Sealant SystemSurgical Specialties México, S. de R.L. de C.V.OMT2016-02-16