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ChibaSono 530S095090

by Pajunk GmbH Medizintechnologie

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 Number04048223088388 UDI-DI Date10 Jun 2026ListedStatusListed 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  • Withdrawn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
ChibaSono
Generic Name
Body aspiration needle, single-use
Model / Ref / Catalog
530S095090
Primary DI / UDI-DI
04048223088388
510(k) Number
FDA Product Code
FCG
GMDN Term
Body aspiration needle, single-use
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 90.0 Millimeter
Needle Gauge — 20.0 Gauge

Related devices

Cleared under the same submission (K113209)

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

Properties

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

Other properties (9)

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