TruPWR Torque Limiting Attachment, 14 Nm 228-TXRX-002

GUDID 00857676008355

Eca Medical Instruments

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00857676008355
NIH Device Record Key57bdf9c0-5a20-499e-ba77-d66de12e2f99
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruPWR Torque Limiting Attachment, 14 Nm
Version Model Number14 Nm
Catalog Number228-TXRX-002
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
GS100857676008355 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-08
Device Publish Date2023-02-28

Devices Manufactured by Eca Medical Instruments

00857676008591 - Palm Handle, 2 mm Hex Torque Limiting Instrument2024-06-03
00857676008607 - Threaded Trimmable Fixation Nail H/W Instrument Pack2024-06-03
00857676008614 - Threaded Trimmable Fixation Nail F/A Instrument Pack2024-06-03
00857676008621 - Threaded Trimmable Fixation Nail Sizing Guide Pack2024-06-03
00857676008553 - iFUSE INTRA X Mallet2024-03-26
00857676008560 - iFUSE INTRA X Assist2024-03-26
00857676008577 - Orthopedic Cannulated Nail Instrument Pack 3.0 x 50mm2024-03-26
00857676008584 - Orthopedic Cannulated Nail Instrument Pack 4.0 x 100mm2024-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.