FIXIT & ecoFIX EPA9000241

GUDID 03760154009744

Punch Tap to be used with diameter 5.5 mm and 6.5 mm FIXIT and ecoFIX suture anchors for rotator cuff repair.

S.B.M

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable
Primary Device ID03760154009744
NIH Device Record Key8d178862-4664-4565-aaf9-7ee755f801d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIXIT & ecoFIX
Version Model NumberPunch Tap - 5.5 mm and 6.5 mm
Catalog NumberEPA9000241
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
GS103760154009744 [Primary]

FDA Product Code

HWXTap, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

Moist Heat or Steam Sterilization


[03760154009744]

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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