Threaded Trimmable Fixation Nail Beveled Instrument Pack 967-005

GUDID 00850078396068

Eca Medical Instruments

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00850078396068
NIH Device Record Key853fea7e-fca6-43bf-b1af-284b2e43e3d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreaded Trimmable Fixation Nail Beveled Instrument Pack
Version Model Number967-005
Catalog Number967-005
Company DUNS084330422
Company NameEca Medical Instruments
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850078396068 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-03
Device Publish Date2025-08-26

Devices Manufactured by Eca Medical Instruments

00850078396112 - TransLoc 3D, 18” Wire and Measurement Guide2025-11-25
00850078396006 - MIS Bunion - Elevator (47-0030-S)2025-11-19
00850078396013 - MIS Bunion Accessory Kit (47-0028-S)2025-11-19
00850078396020 - MIS Bunion - 2.2 x 20mm Burr (47-0029-S)2025-11-19
00850078396037 - MIS Bunion - 1.6mm Guide Wire (x2) (47-0031-S)2025-11-19
00850078396044 - MIS Bunion - 2.0mm Guide Wire (x2) (47-0032-S)2025-11-19
00857676008881 - Arsenal Foot™ Joint Prep Kit (330-00-100)2025-11-19
00857676008928 - Acutrak 3 MIS Bunion Instrument Kit, 4.0, 3.5, 2.5 (47-0020-S)2025-11-19

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.