FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344165544
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDKT0029
Catalog number
MDKT0029
Device description
DRILL KIT, 2.9MM 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
10197344165544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734416554410197344165544

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
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24
10653160395720MEDLINEDYNDC3637DYNDC36372026-10-24
10653160395751MEDLINEECVC8657ECVC86572026-10-24
10653160395782MEDLINEEBSI1426BEBSI1426B2026-10-24
10653160395799MEDLINEECVC2440CECVC2440C2026-10-24
10653160395805MEDLINEEBSI1687AEBSI1687A2026-10-24
10653160395812MEDLINEEBSI1356AEBSI1356A2026-10-24
10653160395850MEDLINEECVC7295AECVC7295A2026-10-24
10653160395867MEDLINEEBSI1590AEBSI1590A2026-10-24
10653160395881MEDLINEECVC2770AECVC2770A2026-10-24
10653160395911MEDLINEEBSI1529AEBSI1529A2026-10-24
10653160395959MEDLINEDYNDV2823DYNDV28232026-10-24
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10884389194775MEDLINEMDS9911MDS99112016-10-14
10884389194799MEDLINEMDS9911MQMDS9911MQ2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956585843CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956586598CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956593176CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956594807CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23