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SmartBand EMR Pack SBEMRP94

by US Endoscopy

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00724995247324 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SmartBand EMR Pack
Generic Name
Endoscopic electrosurgical mucosal biopsy/resection set
Model / Ref / Catalog
SBEMRP94
Primary DI / UDI-DI
00724995247324
510(k) Number
FDA Product Code
FDI
GMDN Term
Endoscopic electrosurgical mucosal biopsy/resection set
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No