Home GUDID 00841193122465 EVOL®SI Joint Fusion System
Primary DI 00841193122465
Brand EVOL®SI Joint Fusion System
Company Cutting Edge Spine, LLC
Model CES-302
Catalog number CES-302
Device description EVOL®SI, 7.5mm Cannulated Drill
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 00841193122465 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 00841193122465 00841193122465 841193122465 0841193122465
GMDN Terms# Term, Definition table Term Definition Cannulated surgical drill bit, reusable A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable 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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