Threaded Trimmable Fixation Nail H/W Instrument Pack 967-001

GUDID 00857676008607

Eca Medical Instruments

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00857676008607
NIH Device Record Key84a4cd26-4a77-4e7c-b774-e7cbc99c61a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreaded Trimmable Fixation Nail H/W Instrument Pack
Version Model NumberH/W Pack
Catalog Number967-001
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
GS100857676008607 [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 Date2024-06-03
Device Publish Date2024-05-24

Devices Manufactured by Eca Medical Instruments

00857676008638 - Threaded Trimmable Fixation Nail Instrument Pack 5.52024-10-29
00857676008201 - TruFIX2024-07-25
00857676008218 - TruFIX2024-07-25
00857676008300 - TruTorq 2024-07-25
00857676008515 - TruTorq 2024-07-25
00857676008522 - TruTorq 2024-07-25
00857676008539 - TruTorq 2024-07-25
00857676008591 - Palm Handle, 2 mm Hex Torque Limiting Instrument2024-06-03

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