AccessGUDID - DEVICE: SHARP NAVIGATION PROBE (03760244030474)

GUDID

Device Identifier (DI) Information

Brand Name: SHARP NAVIGATION PROBE
Version or Model: MALI-170A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ROSAS00132
Company Name: MEDTECH

Primary DI Number: 03760244030474
Issuing Agency: GS1
Commercial Distribution End Date: April 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 264502977 *Terms of Use

Device Description: Sharp navigation probe instrument Rosa one (spine application) Straight navigation probe, sharp

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
45199	Multi-purpose stereotactic surgery system	An electrically-powered 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 a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. 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
OLO	Orthopedic 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: 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: 3ef27cdb-de7f-43e7-8674-1fd908fae3e5
Public Version Date: May 30, 2025
Public Version Number: 8
DI Record Publish Date: November 18, 2019