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InfiltraLong 420 001158-00D

by Pajunk GmbH Medizintechnologie GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048223070130 UDI-DIDate10 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
InfiltraLong 420
Generic Name
Peripheral anaesthesia catheter set, non-medicated
Model / Ref / Catalog
001158-00D
Primary DI / UDI-DI
04048223070130
510(k) Number
FDA Product Code
BSO
GMDN Term
Peripheral anaesthesia catheter set, non-medicated
Device Class
Class II
Regulation Number
868.5120
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Catheter Gauge — 19.0 French
Length — 116.0 Millimeter
Needle Gauge — 18.0 Gauge

Related devices

Cleared under the same submission (K080675)

Show all (12)

Other devices from Pajunk GmbH Medizintechnologie

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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