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Epistat® 1527031

by Medtronic Xomed Inc 2 variants

Epistat® 1527031 is a Class I device made by Medtronic Xomed Inc, listed in FDA GUDID since 13 Oct 2017 (UDI-DI 00681490042109), registry data as of 8 Nov 2026.

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

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00681490042109 UDI-DI Date13 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Epistat®
Generic name
Nasal haemostatic balloon
Model / reference
1527031
Primary DI / UDI-DI
00681490042109
FDA product code
EMX
GMDN term
Nasal haemostatic balloon
Device class
Class I
Regulation number
874.4100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal haemostatic balloon

Similar devices in this category

Other devices filed under Nasal haemostatic balloon.

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)