AccessGUDID - DEVICE: Ball Joint Guide Array (BJGA)-Guide Set (08720892330833)

GUDID

Device Identifier (DI) Information

Brand Name: Ball Joint Guide Array (BJGA)-Guide Set
Version or Model: 66294
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bayer Medical Care B.V.

Primary DI Number: 08720892330833
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 491124978 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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 [?]
K250893	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 908bc248-9891-4074-91e7-107da9273a4f
Public Version Date: May 04, 2026
Public Version Number: 1
DI Record Publish Date: April 24, 2026