FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327233212
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ83134
Catalog number
DYNJ83134
Device description
NEURO PACK
Published
2022-09-04
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
40195327233212PackageGS12In Commercial Distribution
10195327233211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532723321240195327233212
1019532723321110195327233211

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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS14766C0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-09-26
10198956466838CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956497382CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956502604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956513143CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956553910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956559752CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956565616CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956567818CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956568549CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956579194CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956581746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956582378CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956584662CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956585751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956586895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587335CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587663CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587724CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956588431CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956588622CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956589797CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956589995CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590021CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590250CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10809160538951HalyardAVID MEDICAL, INC.OJG2026-09-24
10198956313897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956488366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956489196CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22