AccessGUDID - DEVICE: Unibody™ Bone Fiducials (10mm) (10873263007744)

GUDID

Device Identifier (DI) Information

Brand Name: Unibody™ Bone Fiducials (10mm)
Version or Model: FM-4010-00774
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FM-4010
Company Name: FHC, INC.

Primary DI Number: 10873263007744
Issuing Agency: GS1
Commercial Distribution End Date: January 30, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Stereotactic System

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:	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?
32568	Neurological 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 neurosurgery. 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
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033619	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -34 and 57 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a01167e8-1b28-419f-9d16-70f3ae087d87
Public Version Date: January 31, 2024
Public Version Number: 2
DI Record Publish Date: November 02, 2020