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ReShape™ Integrated Dual Balloon System RSM101

by Reshape Medical, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB001RSM1011 UDI-DI Date25 Aug 2015ListedStatusListed 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  • Withdrawn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
ReShape™ Integrated Dual Balloon System
Generic Name
Appetite-suppression gastric balloon
Model / Ref / Catalog
RSM101
Primary DI / UDI-DI
B001RSM1011
FDA Product Code
LTI
GMDN Term
Appetite-suppression gastric balloon
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Properties

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

Other properties (8)

  • 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