FIXIT & ecoFIX EPA9000101

GUDID 03760154003360

FIXIT® / ecoFIX® cleaning and sterilization basket.

S.B.M

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID03760154003360
NIH Device Record Keybd415ad0-d98f-4bab-b291-a5da0381f445
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIXIT & ecoFIX
Version Model NumberCleaning and sterilization basket
Catalog NumberEPA9000101
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
GS103760154003360 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


[03760154003360]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-29
Device Publish Date2023-12-21

On-Brand Devices [FIXIT & ecoFIX]

03760154002882FIXIT mallet to be used with FIXIT suture anchors for rotator cuff repair.
03760154009744Punch Tap to be used with diameter 5.5 mm and 6.5 mm FIXIT and ecoFIX suture anchors for rotator
03760154009737Punch Tap to be used with diameter 4.5 mm FIXIT and ecoFIX suture anchors for rotator cuff repai
03760154003360FIXIT® / ecoFIX® cleaning and sterilization basket.

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