FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489190779
Brand
MEDLINE
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
DYNDH1512
Catalog number
DYNDH1512
Device description
UCLA - BREAST BIOPSY KIT
Published
2020-04-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXPBreast biopsy / localization tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXPBreast Biopsy / Localization TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489190776PackageGS120In Commercial Distribution
10193489190779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919077620193489190776
1019348919077910193489190779

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, medicatedA collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956201804CARDINAL HEALTHCardinal Health 200, LLCPXP2026-06-01
10198956346833CARDINAL HEALTHCardinal Health 200, LLCPXP2026-03-02
50198956346831CARDINAL HEALTHCardinal Health 200, LLCPXP2026-03-02
10198956340343CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-17
50198956340341CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-17
10197106922507CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-09
50197106922505CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-09
10198956291409CARDINAL HEALTHCardinal Health 200, LLCPXP2026-01-15
50198956291407CARDINAL HEALTHCardinal Health 200, LLCPXP2026-01-15
10198956287945CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
10198956294929CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956287943CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956294927CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
10198956239425CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-11
50198956239423CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-11
10198956259980CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-02
50198956259988CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-02
10198956260917CARDINAL HEALTHCardinal Health 200, LLCPXP2025-11-28
50198956260915CARDINAL HEALTHCardinal Health 200, LLCPXP2025-11-28
10198956190863CARDINAL HEALTHCardinal Health 200, LLCPXP2025-09-09
50198956190861CARDINAL HEALTHCardinal Health 200, LLCPXP2025-09-09
10198956155619CARDINAL HEALTHCardinal Health 200, LLCPXP2025-08-27
50198956155617CARDINAL HEALTHCardinal Health 200, LLCPXP2025-08-27
10198956129252CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-24
50198956129250CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-24
10198956119130CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-21
50198956119138CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-21
10197106928684CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-11
50197106928682CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-11
10197106981917CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-07