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Symphony OPX™ Proliferative Bioscaffold SY03HA004H

by Aroa Biosurgery Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09421908222638 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Symphony OPX™ Proliferative Bioscaffold
Generic Name
Animal-derived wound matrix dressing
Model / Reference
SY03HA004H
Primary DI / UDI-DI
09421908222638
510(k) Number
FDA Product Code
KGN
GMDN Term
Animal-derived wound matrix dressing
Device Class
U
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Area/Surface Area — 4 Square centimeter

Related devices

Cleared under the same submission (K200413)

Show all (12)

Other devices from Aroa Biosurgery

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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