FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327555581
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ61449A
Catalog number
DYNJ61449A
Device description
RADIOLOGY NEURO DRAPE PAC
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327555581PackageGS13In Commercial Distribution
10195327555580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532755558140195327555581
1019532755558010195327555580

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.

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
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489375657NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10193489376845NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10080196471096NAMICMEDLINE INDUSTRIES, INC.OJG2026-04-24
10193489214383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489218220Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489417609Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489419641Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489422245Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489422719Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489423198Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489426984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489427943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444148Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444810Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489447231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489451474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489455335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489458145Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489429367Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-01-01
10193489453355Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2022-11-23
H65857032045Henry ScheinHENRY SCHEIN, INC.OJG2022-10-06
10080196192717NAMICMEDLINE INDUSTRIES, INC.OJG2022-09-04
10193489398878Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2022-08-04
10193489887587Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2022-08-04
10193489314922Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2022-01-16
10193489852424Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2021-11-15
10193489854589Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2021-11-15
10193489867213Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2021-11-15
10193489892727Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2021-11-15