AccessGUDID - DEVICE: Guide (00196852441754)

GUDID

Device Identifier (DI) Information

Brand Name: Guide
Version or Model: MTPG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Mirrorme3d, LLC

Primary DI Number: 00196852441754
Issuing Agency: GS1
Commercial Distribution End Date: February 16, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 060396278 *Terms of Use

Device Description: Patient specific, 3D printed, single-use surgical positioning guide based on a patient’s treatment plan. RX only, non-diagnostic.

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?
60826	Custom-made orthopaedic/craniofacial surgical guide	A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

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: 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: 4a2394e0-cde2-4e77-8ca0-0fe357081470
Public Version Date: February 17, 2023
Public Version Number: 2
DI Record Publish Date: October 03, 2022