Home GUDID 00840916103866 IO-FLEX
Primary DI 00840916103866
Brand IO-FLEX
Company SPINAL ELEMENTS
Model iO-Tome7.5
Device description IO-Flex Microblade Shaver IO-Tome Device 7.5mm
Published 2017-06-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name HAE Rongeur, Manual
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HAE Rongeur, Manual Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840916103866 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 00840916103866 00840916103866 840916103866 0840916103866
GMDN Terms# Term, Definition table Term Definition Spinal curette A hand-held, sterile surgical instrument used to scrape and score the cancellous vertebral bone of the spine, typically during a percutanous, minimally-invasive procedure. It consists of a long, thin, metal shaft that terminates distally in a mushroom-like cutting head that can be set at alternative angles (up to ninety degrees). The device enables a smooth scoring action for the creation of grooves or channels, and is typically used as an adjunct device in the treatment of vertebral compression fractures (VCFs) during kyphoplasty. This is a single-use device.
Regulatory Flags# DUNS number 004022104 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B382SD9228132210 Surgical Direct Surgical Direct, Inc. HAE 2026-10-20 B382SD9228132220 Surgical Direct Surgical Direct, Inc. HAE 2026-10-20 00840217900089 Wiggins Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900096 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900171 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900188 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900195 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900201 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900218 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900225 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900232 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900249 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900256 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900263 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900270 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900287 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900294 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900300 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900317 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900324 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900331 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900348 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900355 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900362 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900379 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900386 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900393 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900409 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900416 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29 00840217900423 Ace Medical EBNER MEDICAL, LLC HAE 2021-03-29