FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327073788
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ52404F
Catalog number
DYNJ52404F
Device description
ORAL SURGERY PACK
Published
2022-06-11
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
40195327073788PackageGS13In Commercial Distribution
10195327073787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532707378840195327073788
1019532707378710195327073787

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
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487093CARDINAL HEALTHCardinal Health 200, LLCOFX2026-05-25
50198956366891CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-23
50198956321296CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-19
50198956351705CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956351743CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956214741CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-09
50198956355024CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-06
50198956334357CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336641CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336627CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956386998CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956177091CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366457CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366884CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-13
50198956285253CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956345179CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956199673CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-30
50197106904334CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-23
50198956103137CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-05
50198956267006CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-31
50198956288452CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-17
50198956210057CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-10
50198956217704CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956285031CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956277593CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-28
50198956281576CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-25
50198956259179CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956266986CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956273199CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956158120CARDINAL HEALTHCardinal Health 200, LLCOFX2025-09-29