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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

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