FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327603267
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1977
Catalog number
DYNDH1977
Device description
STEREOTACTIC BIOPSY TRAY
Published
2024-01-21
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
OFGCT biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327603268PackageGS147In Commercial Distribution
10195327603267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532760326840195327603268
1019532760326710195327603267

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
Premarket exempt
true
Kit
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
10080196456765MEDLINEVDYND20302VDYND203022026-07-14
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13
10080196316809MedlineMSC8722EPMSC8722EP2023-08-15
10080196316816MedlineMSC8744EPMSC8744EP2023-08-15
10193489081053MedlineMSC8422MSC84222023-08-15
10193489081060MedlineMSC8444MSC84442023-08-15
10197344039821MEDLINEHNY19075HNY190752024-10-11
10884389122952MedlineMSC871X8EPMSC871X8EP2023-08-15
10884389155448MedlineMSC8488MSC84882023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956494589CARDINAL HEALTHCardinal Health 200, LLCOFG2026-07-06
10198956514713CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-23
10198956459946CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-01
10195327227777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-13
10193489376449Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489417500Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489427080Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489427325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489429336Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489434958Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489442328Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489449211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489452143Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327028084Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327054588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327092696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489444995Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-04-30
10195327228477Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-28
10195327222550Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-14
10195327222987Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-14
10195327224783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-14
10195327214180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-04
10195327208165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327208554Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327213336Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327195847Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327202934Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327204921Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327197773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11
10195327199975Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11