FDA.reportPublic FDA data

PragmaTool

Primary DI
06973877660414
Brand
PragmaTool
Company
Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Model
801962000
Device description
Retrograde Reamer, Tibia, 9.5mm, S
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06973877660414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973877660414069738776604146973877660414

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, reusableA collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
06973877662722RemoHip8019429002023-05-22
06973877662739RemoHip8019433002023-05-22
06973877662746RemoHip8019435002023-05-22
06973877662753RemoHip8019432002023-05-22
06973877662760RemoHip8019438002023-05-22
06973877662777RemoHip8019409002023-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
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