FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277733213
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA2447
Catalog number
DYNDA2447
Device description
LIVER RENAL BIOPSY TRAY- CHOICE
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PYALiver biopsy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYALiver Biopsy KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277733210PackageGS115In Commercial Distribution
10888277733213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827773321020888277733210
1088827773321310888277733213

GMDN Terms#

Term, Definition table
TermDefinition
Liver biopsy procedure kitA collection of sterile devices, equipment, and supplies used to obtain a tissue specimen from the liver of a patient for histological analysis. It typically contains a biopsy needle, a stylet, syringes, and a scalpel. The specimen is aspirated through the needle when in situ using the syringe. 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
10080196144310MEDLINEDYNDX51813DYNDX518132026-06-08
10884389123997MEDLINEDYNDX50251DYNDX502512026-06-08
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160272168CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPYA2022-01-02
00653160272161CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPYA2022-01-02
00653160009187CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPYA2022-01-01
50653160009182CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPYA2022-01-01
20888277733210MEDLINEMEDLINE INDUSTRIES, INC.PYA2020-05-11
10193489196542MEDLINEMEDLINE INDUSTRIES, INC.PYA2020-04-25
20193489196549MEDLINEMEDLINE INDUSTRIES, INC.PYA2020-04-25