FDA.reportPublic FDA data

Tandry Orthopedic Manual Surgical Instrument

Primary DI
04719879398007
Brand
Tandry Orthopedic Manual Surgical Instrument
Company
MICROWARE PRECISION CO., LTD.
Model
303004A-Z00
Device description
DOUBLE DRILL GUIDE 3.5/2.5, FOR DRILL BITS Ø3.5/2.5mm
Published
2025-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719879398007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879398007047198793980074719879398007

GMDN Terms#

Term, Definition table
TermDefinition
Core body stabilization/exercise stoolA seat designed to be occupied by a patient during exercise or treatment, and/or to improve core body stability whilst seated, typically as part of physiotherapy or ergotherapy. It is in the form of an ergonomically-designed seating platform with no back support (i.e., not a chair) intended to facilitate muscular activation/exercise.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
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07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
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08800089436040Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436057Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436064Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436071Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436088Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436095Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436101Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17