FDA.reportPublic FDA data

MEDLINE

Primary DI
20193489191445
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA1224B
Catalog number
DYNDA1224B
Device description
BREAST BIOPSY KIT
Published
2020-04-20
Public version status
New
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
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
20193489191445PackageGS120In Commercial Distribution
10193489191448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919144520193489191445
1019348919144810193489191448

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956346831CARDINAL HEALTHCardinal Health 200, LLCPXP2026-03-02
50198956340341CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-17
50197106922505CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-09
50198956291407CARDINAL HEALTHCardinal Health 200, LLCPXP2026-01-15
50198956287943CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956294927CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956239423CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-11
50198956259988CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-02
50198956260915CARDINAL HEALTHCardinal Health 200, LLCPXP2025-11-28
50198956190861CARDINAL HEALTHCardinal Health 200, LLCPXP2025-09-09
50198956155617CARDINAL HEALTHCardinal Health 200, LLCPXP2025-08-27
50198956129250CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-24
50198956119138CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-21
50197106928682CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-11
50197106981915CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-07
50197106923281CARDINAL HEALTHCardinal Health 200, LLCPXP2025-01-23
00653160384895MEDLINEMEDLINE INDUSTRIES, INC.PXP2025-01-23
00653160384123MEDLINEMEDLINE INDUSTRIES, INC.PXP2025-01-13
00884838127609DUNLEE SENTINELLEPhilips Medical Systems Nederland B.V.PXP2025-01-10
00884838119451Philips SentinellePhilips Medical Systems Nederland B.V.PXP2024-12-17
00884838119468Philips SentinellePhilips Medical Systems Nederland B.V.PXP2024-12-17
50197106827534CARDINAL HEALTHCardinal Health 200, LLCPXP2024-11-25
50197106743933CARDINAL HEALTHCardinal Health 200, LLCPXP2024-09-13
00653160378153MEDLINEMEDLINE INDUSTRIES, INC.PXP2024-07-29
00884838118768PhilipsPhilips Medical Systems Nederland B.V.PXP2024-07-18
00884838118775PhilipsPhilips Medical Systems Nederland B.V.PXP2024-07-18
00884838118782PhilipsPhilips Medical Systems Nederland B.V.PXP2024-07-18
50197106665006CARDINAL HEALTHCardinal Health 200, LLCPXP2024-06-15
50197106652532CARDINAL HEALTHCardinal Health 200, LLCPXP2024-06-04
50197106584253CARDINAL HEALTHCardinal Health 200, LLCPXP2024-03-21