FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327587444
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ80452A
Catalog number
DYNJ80452A
Device description
PEDIATRIC DENTAL PACK
Published
2024-07-29
Public version status
New
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
OFXGeneral purpose dental tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327587445PackageGS16In Commercial Distribution
10195327587444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532758744540195327587445
1019532758744410195327587444

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389112090MEDLINEEQX7012EQX70122026-10-09
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10884389931967MEDLINEMSC7366EPMSC7366EP2026-10-09
20193489079804MEDLINEBNS128632BNS1286322026-10-09
30193489079726MEDLINEBNS111718BNS1117182026-10-09
30193489079771MEDLINEBNS119386BNS1193862026-10-09
30193489079788MEDLINEBNS119387BNS1193872026-10-09
30193489079795MEDLINEBNS120988BNS1209882026-10-09
10197344104116MEDLINEPIVBCA18125PIVBCA181252025-02-06
10197344104130MEDLINEPIVBCA20100PIVBCA201002025-02-06
10197344104147MEDLINEPIVBCA20125PIVBCA201252025-02-06
20197344024992MedlineMPH22325HCGMPH22325HCG2024-03-11
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08
10653160394921MEDLINEDYNDC2850ADYNDC2850A2026-10-08
10653160395119MEDLINEDYNDC2762BDYNDC2762B2026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956569980CARDINAL HEALTHCardinal Health 200, LLCOFX2026-10-12
10198956582729CARDINAL HEALTHCardinal Health 200, LLCOFX2026-10-12
10198956583092CARDINAL HEALTHCardinal Health 200, LLCOFX2026-10-12
10198956579552CARDINAL HEALTHCardinal Health 200, LLCOFX2026-09-22
10198956560925CARDINAL HEALTHCardinal Health 200, LLCOFX2026-08-26
10198956522411CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-31
10198956529380CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-27
10198956449596CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-20
10198956464230CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-20
10198956453265CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-06
10198956502895CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-23
10198956464223CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-05
08720892104809Crown Cassette 200Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104823Crown Cassette 100Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104847Crown Cassette 300Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104861Crown Cassette 400Rademaker Medical Instruments B.V.OFX2026-06-04
10198956480858CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-01
10195327485092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327593520Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327608170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327628604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327654252Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327671099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327671136Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327674175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-04-07
10195327640170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
10195327643713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
10195327640408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327641399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25