FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489666670
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1374A
Catalog number
DYNDH1374A
Device description
STEREOTACTIC BREAST BIOPSY
Published
2019-04-14
Public version status
Update
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
FTNPlastic surgery and accessories kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489666670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348966667010193489666670

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
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
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196920846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2025-01-19
10193489425918Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489434392Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-07-29
10193489214390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489214475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489215519Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489406696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489414936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489416183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489418828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419450Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419597Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489419733Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489421743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489424850Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489426311Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489427073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429114Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429299Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489429305Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489439175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489441635Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442670Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08
10193489442687Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FTN2023-06-08