FDA.reportPublic FDA data

Tandry Orthopedic Manual Surgical Instrument

Primary DI
04719879398700
Brand
Tandry Orthopedic Manual Surgical Instrument
Company
MICROWARE PRECISION CO., LTD.
Model
306045A-K00
Device description
SELF-RETAINING HEXALOBULAR T6 CANNULATED SCREWDRIVER
Published
2025-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719879398700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879398700047198793987004719879398700

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719962166575Tandry Orthopedic Manual Surgical Instrument303027A-5002025-11-12
04719962166599Tandry Orthopedic Manual Surgical Instrument304001A-5002025-11-12
04719962169132Tandry Orthopedic Manual Surgical Instrument306011A-K002025-10-31
04719962169224Tandry Orthopedic Manual Surgical Instrument306050A-K002025-10-31
04719879398014Tandry Orthopedic Manual Surgical Instrument303005A-5002025-08-27
04719879398182Tandry Orthopedic Manual Surgical Instrument304007A-5002025-08-27
04719879398052Tandry Orthopedic Manual Surgical Instrument303012B-K002025-08-22
04719879398069Tandry Orthopedic Manual Surgical Instrument303013A-Z002025-08-22
04719879398113Tandry Orthopedic Manual Surgical Instrument303020A-K002025-08-22
04719879398199Tandry Orthopedic Manual Surgical Instrument304008A-K002025-08-22
04719879398229Tandry Orthopedic Manual Surgical Instrument304011A-Z002025-08-22
04719879398328Tandry Orthopedic Manual Surgical Instrument306027A-K002025-08-22
04719879398045Tandry Orthopedic Manual Surgical Instrument303012A-K002025-05-07
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

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Primary DI, Brand, Company table
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00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191944Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
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10887587078557NASynthes GmbHHXX2026-07-24
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00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
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00888118154682LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154699LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154705LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154712LEVEL ONEKLS-Martin L.P.HXX2026-07-21
00199150072323Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-19