AccessGUDID - DEVICE: Unibody™ Bone Fiducials (13mm) (10873263008574)

GUDID

Device Identifier (DI) Information

Brand Name: Unibody™ Bone Fiducials (13mm)
Version or Model: FM-4013-00857
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FM-4013
Company Name: FHC, INC.

Primary DI Number: 10873263008574
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: Unibody™ Bone Fiducials (13mm) for use with the Nexframe® Sterotactic 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: 4da6f00b-824e-45b9-92c2-b788ffeb0fb0
Public Version Date: May 26, 2022
Public Version Number: 1
DI Record Publish Date: May 18, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00873263008577 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)326-2905
Email: fhcinc@fh-co.com

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