FDA.reportPublic FDA data

BioSentry®

Primary DI
00884450808122
Brand
BioSentry®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
H787768022019S1
Published
2024-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMTAbsorbable lung biopsy plug

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450808122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450808122008844508081228844508081220884450808122

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

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19
10884450114770Prelude IDeal™HPID5F11021PW2026-06-20
10884450115982Prelude IDeal™HPID7F16021PW2026-09-15
10884450118679Prelude EASE™JPHR4F7018SC2026-10-27
10884450438517Prelude® PROJPRO-7F-11-035MT2026-09-15
10884450438586Prelude® PROJPRO-8F-11-035MT2026-09-15
10884450439439Prelude IDeal™JPID4F7018NTPD2026-09-01
10884450451141Prelude SNAP™DPLS-10072026-09-12
10884450451783Prelude SNAP™DPLS-10062026-09-12
10884450451790Prelude SNAP™DPLS-1008.52026-09-12
10884450451806Prelude SNAP™DPLS-10082026-09-12
10884450451813Prelude SNAP™DPLS-1009.52026-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782023141BioSentry™ Tract Sealant SystemSurgical Specialties México, S. de R.L. de C.V.OMT2016-02-16
10848782023148BioSentry™ Tract Sealant SystemSurgical Specialties México, S. de R.L. de C.V.OMT2016-02-16