FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40884389642512
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ24480F
Catalog number
DYNJ24480F
Device description
GYN ONCOLOGY-LF
Published
2016-11-07
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
OJFHysterectomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389642512PackageGS16In Commercial Distribution
10884389642511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438964251240884389642512
1088438964251110884389642511

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@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
true
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
10198956544451CARDINAL HEALTHCardinal Health 200, LLCOJF2026-08-17
10198956342217CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-31
10197106886960CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956491090CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956535374CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956536647CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956423046CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956492127CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956515468CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956520288CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956492103CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956492363CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956496330CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956498389CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956525504CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956526020CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10198956488069CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
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