FDA.reportPublic FDA data

Medline

Primary DI
10197344000722
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MSK51818
Catalog number
MSK51818
Device description
STAPLE KIT, REFLEX ULTRA, 18 X 18MM
Published
2024-03-15
Public version status
New
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
JDRStaple, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344000722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734400072210197344000722

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.JDR2026-03-30
00810111224833TMC Nanoplasty SystemTreace Medical Concepts, Inc.JDR2025-10-10
00811714036458Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
00811714036465Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042640Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042671Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042688Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00811714035352Thunderbolt PlateRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
07630971238039MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238046MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238053MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238060MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238077MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238084MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238091MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238107MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238114MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238121MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
00815432025138MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2018-08-06