FDA.reportPublic FDA data

MEDINAUT-Ix

Primary DI
08800038060241
Brand
MEDINAUT-Ix
Company
IMEDICOM CO., LTD.
Model
MIX-CA1 / MIX-EX1B
Device description
Cannula(155.5mm) and Bevel type Needle
Published
2025-07-15
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

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800038060241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800038060241088000380602418800038060241

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690340653
Device count
1
Premarket exempt
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
08800038060807EZImpactorBMA-P20-IW12026-04-21
08800038060814EZImpactorBMA-P20-SW12026-04-21
08800038060784EZImpactorBMA-P10-IW12026-04-01
08800038060791EZImpactorBMA-P10-SW12026-04-01
08800038060319EZImpactorBMA-P10-I012026-01-22
08800038060326EZImpactorBMA-P10-S012026-01-22
08800038060333EZImpactorBMA-P20-I012026-01-22
08800038060340EZImpactorBMA-P20-S012026-01-22
08404535020120Brasseler EZXBRXTR2-0012025-10-10
08800038029323SteriSpine VA KITKYPHO102025-09-24
08800038029330SteriSpine VA KITKYPHO152025-09-24
08800038029347SteriSpine VA KITKYPHO202025-09-24
08800038029354SteriSpine VA KITKYPHO10B2025-09-24
08800038029361SteriSpine VA KITKYPHO15B2025-09-24
08800038029378SteriSpine VA KITKYPHO20B2025-09-24
08800038029415SteriSpine VA SPICD-CA2/ SPICD-NDB22025-09-24
08800038029422SteriSpine VA SPICD-CA2/ SPICD-NDT22025-09-24
08800038039407SteriSpine VA SPICD-CA1/ SPICD-NDB12025-09-24
08800038039414SteriSpine VA SPICD-CA1/ SPICD-NDD12025-09-24
08800038039421SteriSpine VA SPICD-CA1/ SPICD-NDT12025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
B382SD9141791400Surgical DirectSurgical Direct, Inc.LXH2026-07-13
B382SD9142211000Surgical DirectSurgical Direct, Inc.LXH2026-07-13
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00190446924838Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00840067212189TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212196TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212202TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212219TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212226TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212233TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212240TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212257TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212264TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212271TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212288TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212295TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212301TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212318TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00889929072752NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072769NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072776NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072783NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
04046826486631Stern-a-Fix Sternal Closure SystemMedicon eG. Chirurgiemechaniker-GenossenschaftLXH2026-06-24