MENIX MEN9000455

GUDID 03760304681622

Suture passer automatic grasper - Knee

S.B.M

Suturing unit, reusable
Primary Device ID03760304681622
NIH Device Record Keya8a50a2d-6b46-4fbf-be1c-2af04ed59ede
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENIX
Version Model NumberSuture passer automatic grasper - Knee
Catalog NumberMEN9000455
Company DUNS772462123
Company NameS.B.M
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760304681622 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760304681622]

Moist Heat or Steam Sterilization


[03760304681622]

Moist Heat or Steam Sterilization


[03760304681622]

Moist Heat or Steam Sterilization


[03760304681622]

Moist Heat or Steam Sterilization


[03760304681622]

Moist Heat or Steam Sterilization


[03760304681622]

Moist Heat or Steam Sterilization


[03760304681622]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-04
Device Publish Date2025-06-26

On-Brand Devices [MENIX]

03760304680533MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed
03760304680779MENIX Arthroscopic scissors to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680762MENIX rasp to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680755MENIX 90 degree probe to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680748MENIX Knot pusher to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680731MENIX Twister to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680557MENIX Suture cutter to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680540MENIX Portal skid to be used with MENIX and MENIX DUO devices in meniscal repair.
03760304680816Complete instrumentation set intended to be used for arthroscopic meniscus repair.
03760304681622Suture passer automatic grasper - Knee

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