FDA.reportPublic FDA data

TracPort

Primary DI
06970399635692
Brand
TracPort
Company
Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Model
810710400
Device description
TracPort Silicone Cannula φ8×30
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
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
06970399635692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970399635692069703996356926970399635692

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. 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
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
06973877662777RemoHip8019409002023-05-22

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Primary DI, Brand, Company table
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00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
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