FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327180172
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ49583D
Catalog number
DYNJ49583D
Device description
DENTAL REHAB PACK
Published
2022-06-19
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
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
40195327180172PackageGS112In Commercial Distribution
10195327180171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532718017240195327180172
1019532718017110195327180171

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
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
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
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
10195327587444Medline 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
10195327619978Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-11
10195327588168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07