Skip to content

Transseptal Puncture Device PTX2-001

by Protaryx Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00199874352930 UDI-DI Date15 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Transseptal Puncture Device
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
PTX2-001
Primary DI / UDI-DI
00199874352930
FDA Product Code
DYB, DXF
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1340, 870.5175
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 63 Centimeter
Outer Diameter — 3.67 Millimeter
Guidewire Diameter — 0.035 Inch

Other devices from Protaryx Medical, Inc.

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