FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10888277928794
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
SPEC0243A
Catalog number
SPEC0243A
Device description
PQ BIOPSY PACK (BPSJH)-LF
Published
2016-11-07
Public version status
Update
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
10888277928794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827792879410888277928794

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA 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 reusable 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
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
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10195327228484Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-28
10195327229559Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-28
10195327229573Medline 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