FIXIT Knotless & ecoFIX Knotless EPA9000315

GUDID 03760154009751

Screwdriver to be used with FIXIT Knotless and ecoFIX Knotless anchors for rotator cuff repair.

S.B.M

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID03760154009751
NIH Device Record Keybb9e576d-aefb-4c3e-bdfd-200625471a0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIXIT Knotless & ecoFIX Knotless
Version Model NumberScrewdriver
Catalog NumberEPA9000315
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
GS103760154009751 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

Moist Heat or Steam Sterilization


[03760154009751]

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

Devices Manufactured by S.B.M

03760154002486 - LIGAFIX2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X5 to be used with LIGAFIX interference screws for ACL reconstruction.
03760154002493 - LIGAFIX2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X10 to be used with LIGAFIX interference screws for ACL reconstruction.
03760154002561 - LIGAFIX2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.
03760154002578 - LIGAFIX2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction.
03760154002608 - LIGAFIX2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X5, for ACL reconstruction.
03760154002615 - LIGAFIX2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X10, for ACL reconstruction.
03760154002622 - LIGAFIX2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X1, for ACL reconstruction.
03760154002639 - LIGAFIX2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.

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