MD-Vue Lateral Access System 54-BK-2000

GUDID 00840019936477

Table Arm Kit

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019936477
NIH Device Record Key30e4d536-7b8f-4c81-8319-ac4a237da98a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD-Vue Lateral Access System
Version Model Number54-BK-2000
Catalog Number54-BK-2000
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019936477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


[00840019936477]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-16
Device Publish Date2023-03-08

On-Brand Devices [MD-Vue Lateral Access System]

00840019936484Light Cable Kit
00840019936477Table Arm Kit
00840019936460Instrument Kit

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