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TunnEler 235 001151-55

by Pajunk GmbH Medizintechnologie GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048223069738 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  • Withdrawn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
TunnEler 235
Generic Name
Subcutaneous tunneller, single-use
Model / Ref / Catalog
001151-55
Primary DI / UDI-DI
04048223069738
FDA Product Code
GDF
GMDN Term
Subcutaneous tunneller, single-use
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 235.0 Millimeter

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

Properties

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

Other properties (8)

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