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Prager Shell® P-104

by Esi, Inc.

Prager Shell P-104 is an eye wash cup (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Esi, Inc., cleared under FDA 510(k) K082893 on 5 Dec 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B360P1040), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K082893

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB360P1040 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082893 Date5 Dec 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082893 decided 5 Dec 2008 Active
  • FDA GUDID UDI-DI B360P1040 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082893
  2. Listed FDA GUDID B360P1040

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Prager Shell®
Generic name
Eye wash cup
Model / Ref / Catalog
P-104
Primary DI / UDI-DI
B360P1040
510(k) Number
FDA product code
ITX
GMDN term
Eye wash cup
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 15.7 Millimeter
Lumen/Inner Diameter — 14 Millimeter

Related devices

Category: Eye wash cup

Cleared under the same submission (K082893)

and 8 more cleared under K082893

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Esi, Inc.

See all devices from Esi, Inc. →

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)