MENIX / FIXIT / ecoFIX ANS9005461

GUDID 03760304681646

Non sterile needle (x5)

S.B.M

Suturing needle, reusable
Primary Device ID03760304681646
NIH Device Record Key8025d531-4ca0-490a-9abf-291ffbb1845b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMENIX / FIXIT / ecoFIX
Version Model NumberNon sterile needle (x5)
Catalog NumberANS9005461
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
GS103760304681646 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760304681646]

Moist Heat or Steam Sterilization


[03760304681646]

Moist Heat or Steam Sterilization


[03760304681646]

Moist Heat or Steam Sterilization


[03760304681646]

Moist Heat or Steam Sterilization


[03760304681646]

Moist Heat or Steam Sterilization


[03760304681646]

Moist Heat or Steam Sterilization


[03760304681646]

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 / FIXIT / ecoFIX]

03760304681653Non sterile needle (x10)
03760304681646Non sterile needle (x5)
03760304681639Non sterile needle (x1)

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