Home GUDID 00841193100487 EVOL®SI Joint Fusion System
Primary DI 00841193100487
Brand EVOL®SI Joint Fusion System
Company Cutting Edge Spine, LLC
Model CES-290
Catalog number CES-290
Device description EVOL®SI, Adjustable Wire Guide
Published 2019-08-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841193100487 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841193100487 00841193100487 841193100487 0841193100487
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone wire A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 069472647 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841193127996 T-FIX™3Dsi Joint Fusion System CES-643 2026-03-24 00841193127521 EVOL®ha-Hyper C Cervical Interbody System 6012-0507A 6012-0507A 2026-03-11 00841193127538 EVOL®ha-Hyper C Cervical Interbody System 6012-0607A 6012-0607A 2026-03-11 00841193127545 EVOL®ha-Hyper C Cervical Interbody System 6012-0707A 6012-0707A 2026-03-11 00841193127552 EVOL®ha-Hyper C Cervical Interbody System 6012-0807A 6012-0807A 2026-03-11 00841193127569 EVOL®ha-Hyper C Cervical Interbody System 6012-0907A 6012-0907A 2026-03-11 00841193127576 EVOL®ha-Hyper C Cervical Interbody System 6012-1007A 6012-1007A 2026-03-11 00841193127583 EVOL®ha-Hyper C Cervical Interbody System 6012-1107A 6012-1107A 2026-03-11 00841193127590 EVOL®ha-Hyper C Cervical Interbody System 6012-1207A 6012-1207A 2026-03-11 00841193127606 EVOL®ha-Hyper C Cervical Interbody System 6013-0512A 6013-0512A 2026-03-11 00841193127613 EVOL®ha-Hyper C Cervical Interbody System 6013-0612A 6013-0612A 2026-03-11 00841193127620 EVOL®ha-Hyper C Cervical Interbody System 6013-0712A 6013-0712A 2026-03-11 00841193127637 EVOL®ha-Hyper C Cervical Interbody System 6013-0812A 6013-0712A 2026-03-11 00841193127644 EVOL®ha-Hyper C Cervical Interbody System 6013-0912A 6013-0912A 2026-03-11 00841193127651 EVOL®ha-Hyper C Cervical Interbody System 6013-1012A 6013-1012A 2026-03-11 00841193127668 EVOL®ha-Hyper C Cervical Interbody System 6013-1112A 6013-1112A 2026-03-11 00841193127675 EVOL®ha-Hyper C Cervical Interbody System 6013-1212A 6013-1212A 2026-03-11 00841193127989 T-FIX®3DSI Joint Fusion System CES-550 2025-07-25 00841193124995 EVOL®SI Joint Fusion System CES-318 2024-04-26 00841193126562 T-FIX™3Dsi Joint Fusion System CES-552 2024-04-05
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