AccessGUDID - DEVICE: Neocis Guidance System (00810004900356)

GUDID

Device Identifier (DI) Information

Brand Name: Neocis Guidance System
Version or Model: DRW-0910-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEOCIS INC

Primary DI Number: 00810004900356
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 802312434 *Terms of Use

Device Description: Mandible EPS (Left)

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:	Yes
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?
45197	Dental stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLV	Dental Stereotaxic Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 7a17a69a-18de-42e4-8b84-bb974cedef40
Public Version Date: February 09, 2023
Public Version Number: 2
DI Record Publish Date: July 28, 2020