FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489904421
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ58446C
Catalog number
DYNJ58446C
Device description
DR HART'S HAND PACK
Published
2021-09-01
Public version status
Update
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
OJHOrthopedic tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489904421PackageGS13In Commercial Distribution
10193489904420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348990442140193489904421
1019348990442010193489904420

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
true
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
false
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
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
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10198956542631CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
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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
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10198956567429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567771CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
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10198956569256CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
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10198956570900CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
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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