FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277960411
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
SPEC0076G
Catalog number
SPEC0076G
Device description
STEREO BIOPSY PACK-LF
Published
2020-08-19
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
40888277960412PackageGS120In Commercial Distribution
10888277960411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827796041240888277960412
1088827796041110888277960411

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(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
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
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

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