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ACUITY® Pro 8115

by Boston Scientific 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00802526626807 UDI-DI Date17 Jan 2025ListedStatusListed 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  • Withdrawn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
ACUITY® Pro
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
8115
Primary DI / UDI-DI
00802526626807
FDA Product Code
DQY
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution
Size
Catheter Length — 45 Centimeter
Outer Diameter — 3.1 Millimeter

Related devices

Category: Vascular guide-catheter, single-use

Other devices from Boston Scientific

See all devices from Boston Scientific →

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