FDA.reportPublic FDA data

Meniscal open cannula

Primary DI
08903837404947
Brand
Meniscal open cannula
Company
HEALTHIUM MEDTECH LIMITED
Model
05.06.10.0100
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08903837404947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08903837404947089038374049478903837404947

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
916326705
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08903837224453MonoglydeE11F90CY192026-08-19
08903837224491MonoglydeE11H90CY162026-08-19
08903837224514TruleneEP56133-452026-08-19
08903837224538TruleneEP66113-452026-08-19
08903837224552TruleneEP66133-452026-08-19
08903837337214MonoglydeE11F90CX19P2026-08-19
08903837337238TruleneE8H45CX13P2026-08-19
08903837337252PDSYNTHE9F75CX19P2026-08-19
08903837402325TrulonE15G75CX13P2026-08-19
08903837402349TruglydeE18F75CX19P2026-08-19
08903837402363TRUSILKE5E75CX26P2026-08-19
08903837402387TRUSILKE5H60CX16P2026-08-19
08903837799265MonoglydeE11G90CY19P2026-08-19
08903837799289MonoglydeE11G90CY16P2026-08-19
08903837799302MonoglydeE14H45CX16P2026-08-19
08903837799326TrulonE15I45CX13P2026-08-19
08903837252722Meniscal open cannulaSingle Lumen2026-08-18
08903837252746Meniscal open cannulaUp/Down2026-08-18
08903837252753Meniscal open cannulaLeft/Right2026-08-18
08903837252760Meniscal open cannulaUp Bend2026-08-18

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10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
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B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
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B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16