FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344165551
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDKT0033
Catalog number
MDKT0033
Device description
DRILL KIT, 3.3MM PUSH ANCHOR
Published
2025-11-14
Public version status
Update
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
NWNLaparoscopic bone anchor urethropexy instrument kit
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWNLaparoscopic Bone Anchor Urethropexy Instrument KitOrthopedic2
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344165551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734416555110197344165551

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
B098AMS199160Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199340Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199930Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS6160F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9487F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9509E0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
10198956374232CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956400801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956424654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956486645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956500730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956512016CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956519275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956524033CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956545151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956545168CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956548299CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956550575CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956551022CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956551091CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956556492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956556638CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956557567CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956558960CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956559646CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560598CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956561212CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25