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AuST Steerable Sheath 0-085H-H2274SAN0-SNSP0

by CenterPoint Systems LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00810024670543 UDI-DI Date12 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AuST Steerable Sheath
Generic Name
Vascular guide-catheter, single-use
Model / Reference
0-085H-H2274SAN0-SNSP0
Primary DI / UDI-DI
00810024670543
510(k) Number
FDA Product Code
DYB, DRA
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1340, 870.1280
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 74 Centimeter

Related devices

Cleared under the same submission (K251051)

Show all (12)

Other devices from CenterPoint Systems LLC

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Properties

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

Other properties (9)

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