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AeroForm® Tissue Expander 400cc Small

by Airxpanders, 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 Number10851452007010 UDI-DI Date21 Jun 2017ListedStatusListed 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  • Withdrawn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
AeroForm® Tissue Expander
Generic Name
Remotely-controlled tissue expander
Model / Ref / Catalog
400cc Small, BR125-400
Primary DI / UDI-DI
10851452007010
FDA Product Code
PQN
GMDN Term
Remotely-controlled tissue expander
Device Class
Class II
Regulation Number
878.3510
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe
Size
Total Volume — 400 Milliliter

Related devices

Category: Remotely-controlled tissue expander

Other devices from Airxpanders, Inc.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No