FDA.reportPublic FDA data

PragmaTool

Primary DI
06973877664009
Brand
PragmaTool
Company
Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Model
RJ8112033
Device description
Retrograde Reamer, D4.0, 9.0mm
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973877664009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973877664009069738776640096973877664009

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560430218
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970399633780RapidLink8106002002023-05-22
06970399635524TracPort8107002002023-05-22
06970399635593TracPort8107009002023-05-22
06970399635692TracPort8107104002023-05-22
06970399635708TracPort8107105002023-05-22
06970399639348EasyPass8013025002023-05-22
06970399639362EasyPass8013030002023-05-22
06972884980966EasyPass8013031002023-05-22
06972884980973EasyPass8019040002023-05-22
06972884983035PragmaTool8019615002023-05-22
06972884983042PragmaTool8019617002023-05-22
06972884983059PragmaTool8019619002023-05-22
06973877660391PragmaTool8019616002023-05-22
06973877660407PragmaTool8019618002023-05-22
06973877660414PragmaTool8019620002023-05-22
06973877662722RemoHip8019429002023-05-22
06973877662739RemoHip8019433002023-05-22
06973877662746RemoHip8019435002023-05-22
06973877662753RemoHip8019432002023-05-22
06973877662760RemoHip8019438002023-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536161836neon3Ulrich GmbH & Co. KGHTW2026-05-28
04052536161867neon3Ulrich GmbH & Co. KGHTW2026-05-28
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24