AccessGUDID - DEVICE: MD Vue Lateral Access (00840019919517)

GUDID

Device Identifier (DI) Information

Brand Name: MD Vue Lateral Access
Version or Model: 54-HD-0200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 54-HD-0200
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019919517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: Fixation Pin Driver

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62771	Neurosurgical retraction system, spinal	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of dorsal tissue to enable access for spinal surgery. It includes a mounting frame, with retracting blades which may come together to form a tube-like port; it may be intended to attach to a fixed arm, e.g., an arm attached to the surgical table. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXX	Screwdriver

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54d75718-8f5f-43ae-b89f-740eaae3821e
Public Version Date: April 04, 2019
Public Version Number: 1
DI Record Publish Date: March 27, 2019