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VersaCross Large Access Transseptal Dilator VLA125-35-67-D0

by Baylis Médicale Cie Inc

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00685447005247 UDI-DI Date10 Jun 2021ListedStatusListed GUDID: not 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  • Withdrawn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
VersaCross Large Access Transseptal Dilator
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
VLA125-35-67-D0
Primary DI / UDI-DI
00685447005247
FDA Product Code
DRE
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1310
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Vascular guide-catheter, single-use

Other devices from Baylis Médicale Cie Inc

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No