FDA.reportPublic FDA data

Ball Joint Guide Array (BJGA)-Guide Set

Primary DI
08720892330833
Brand
Ball Joint Guide Array (BJGA)-Guide Set
Company
Bayer Medical Care B.V.
Model
66294
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250893000Ball Joint Guide Array (66295)Bayer Medical Care, Inc.2025-09-04HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
48720892330831PackageGS14In Commercial Distribution
08720892330833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4872089233083148720892330831
08720892330833087208923308338720892330833

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Regulatory Flags#

DUNS number
491124978
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720892330826Ball Joint Guide Array (BJGA)-Navigation Set662932026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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