FDA.reportPublic FDA data

MEDLINE

Primary DI
20888277733210
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
OTC
false
Sterile
false
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.

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
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
10888277733213MEDLINEMEDLINE INDUSTRIES, INC.PYA2020-05-11
10193489196542MEDLINEMEDLINE INDUSTRIES, INC.PYA2020-04-25
20193489196549MEDLINEMEDLINE INDUSTRIES, INC.PYA2020-04-25