FDA.reportPublic FDA data

Tandry Orthopedic Manual Surgical Instrument

Primary DI
04719879398014
Brand
Tandry Orthopedic Manual Surgical Instrument
Company
MICROWARE PRECISION CO., LTD.
Model
303005A-500
Device description
TAP FOR CORTEX SCREWS Ø3.5mm, LENGTH 110/50mm
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04719879398014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879398014047198793980144719879398014

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886424636275harrisondu@microware.com.tw

Regulatory Flags#

DUNS number
658650833
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873099689BIO-RAY A-1 Anchor Screw SystemA-1H-2120082026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemA-1H-2120102026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemA-1H-2120122026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemA-1H-2120142026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemA-1HS-2220082026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemA-1HS-2220102026-05-15
04719873099771BIO-RAY A-1 Anchor Screw SystemA-1HS-2220122026-05-15
04719873099788BIO-RAY A-1 Anchor Screw SystemA-1HS-2220142026-05-15
04719873100057BIO-RAY A-1 Anchor Screw SystemA-1H-4120082026-05-15
04719873100064BIO-RAY A-1 Anchor Screw SystemA-1H-4120102026-05-15
04719873100071BIO-RAY A-1 Anchor Screw SystemA-1H-4120122026-05-15
04719873100088BIO-RAY A-1 Anchor Screw SystemA-1H-4120142026-05-15
04719873100248BIO-RAY A-1 Anchor Screw SystemA-1PL-4120082026-05-15
04719873100255BIO-RAY A-1 Anchor Screw SystemA-1PL-4120102026-05-15
04719873100262BIO-RAY A-1 Anchor Screw SystemA-1PL-4120122026-05-15
04719873100279BIO-RAY A-1 Anchor Screw SystemA-1PL-4120142026-05-15
04719873100286BIO-RAY A-1 Anchor Screw SystemA-1PL-4120172026-05-15
04719873100354BIO-RAY A-1 Anchor Screw SystemA-1DH-4120082026-05-15
04719873100361BIO-RAY A-1 Anchor Screw SystemA-1DH-4120102026-05-15
04719873100378BIO-RAY A-1 Anchor Screw SystemA-1DH-4120122026-05-15

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