Decima Spine Instrument Kit 6086-01

GUDID 00857360007039

11mm Deciport

DECIMA SPINE, INC.

Orthopaedic trocar blade, reusable
Primary Device ID00857360007039
NIH Device Record Key068bae24-4bff-493d-9414-5211247a32af
Commercial Distribution StatusIn Commercial Distribution
Brand NameDecima Spine Instrument Kit
Version Model Number6086-01
Catalog Number6086-01
Company DUNS080963983
Company NameDECIMA SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (954) 243-6103
Emailcarlos@decimaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857360007039 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00857360007039]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-07
Device Publish Date2018-04-04

On-Brand Devices [Decima Spine Instrument Kit]

00857360007220FCD-2 Removal Kit
00857360007213FCD-2 Stabilizer Removal Tool
00857360007206FCD-2 Removal Cassette Assembly
00857360007145Decima Spine Instrument Kit
00857360007138Decima Spine Instrument Kit, Tray Assembly
00857360007114Cassette Assembly
00857360007107Slap Hammer
00857360007091Tap
00857360007084Pre-Drill
00857360007077REMOVAL DRIVER
00857360007060INSERTION TOOL
00857360007053Driver
00857360007046Countersink
0085736000703911mm Deciport
00857360007015Quick Release Handle
00857360007008Kichner Wire

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