FDA.reportPublic FDA data

EasyPass

Primary DI
06972884980966
Brand
EasyPass
Company
Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Model
801303100
Device description
Suture Passers, Frog, 45° Right
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
HXIPasser, Wire, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972884980966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972884980966069728849809666972884980966

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100127HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100134HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100141HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100295IO FiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100318XMCPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078101889Jones UnionEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110126AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110263AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112267Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112281Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114735Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114766Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116159Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116166Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116180AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078119822Axis PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078123379Omni Stable AFEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078124239Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078126066Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078137178MetaForeEXTREMITY MEDICAL, LLCHXI2026-10-29
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130971DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
04047844130988DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15
00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15