FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489920024
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ0843648J
Catalog number
DYNJ0843648J
Device description
CRANIOTOMY PACK-LF
Published
2021-06-20
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489920024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348992002410193489920024

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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
10653160393900MEDLINEBSIPIV1023BSIPIV10232026-10-01
10888277664395MEDLINEMPHUA120MPMPHUA120MP2026-10-01
20080196181893GeminiGEM1148SGEM1148S2016-10-14
20080196181954GeminiGEM2112SGEM2112S2016-10-14
20080196187307GeminiGEM5172SGEM5172S2016-10-14
20080196921208GeminiGEM2112GEM21122016-10-14
20888277655499MEDLINEMLABTP12GENMLABTP12GEN2026-10-01
10193489011265GeminiGEMTITAN54TGEMTITAN54T2021-05-26
10197344149018GeminiGEMTITAN18TCGEMTITAN18TC2025-08-14
10884389112076MEDLINE INDUSTRIES, INC.EQX7022EQX70222021-05-18
10884389121740MEDLINE INDUSTRIES, INC.EQX7044EQX70442021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196181152GeminiGEM1124SGEM1124S2016-10-14
20080196181367GeminiGEM1130SGEM1130S2016-10-14
20080196181428GeminiGEM1136SGEM1136S2016-10-14
20080196181565GeminiGEM1140SGEM1140S2016-10-14
20080196921130GeminiGEM1124GEM11242016-10-14
20080196921178GeminiGEM1145GEM11452016-10-14
20197344695314GeminiGEM5172SCGEM5172SC2024-07-15
20197344695321GeminiGEM5172TCGEM5172TC2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956333901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956530645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956537262CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956539563CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956542631CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956558915CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956559608CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956560147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562592CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562967CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956563018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956566880CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567771CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956568976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956569256CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570900CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956571549CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956580091CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956582941CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956587373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592353CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592735CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592865CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956593695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956596443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956356122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29
10198956474888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29