Ball Joint Guide Array (BJGA)-Navigation Set 66293

by Bayer Medical Care B.V.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08720892330826 UDI-DI	Date24 Apr 2026Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Ball Joint Guide Array (BJGA)-Navigation Set
Generic Name: Neurological stereotactic surgery system
Model / Reference: 66293

Primary DI / UDI-DI: 08720892330826
510(k) Number: K250893
FDA Product Code: HAW
GMDN Term: Neurological stereotactic surgery system

Device Class: Class II
Regulation Number: 882.4560
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

Other devices from Bayer Medical Care B.V.

Ball Joint Guide Array (BJGA)-Guide Set 66294

Class II

Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (8)

Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No