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Verza Guidance System H48062AV

by Civco Medical Instruments Co., Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841436126359 UDI-DI Date31 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Verza Guidance System
Generic Name
Ultrasound imaging system tracking positioner, reusable
Model / Ref / Catalog
H48062AV
Description
Reusable non-sterile bracket with Verza™ guides (5), (14x91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare 4Sc transducers
Primary DI / UDI-DI
00841436126359
510(k) Number
FDA Product Code
ITX
GMDN Term
Ultrasound imaging system tracking positioner, reusable
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K160806)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No