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Prager Shell®

FDA UDI

Class II (US FDA UDI)

by Esi, Inc.

Identity

Trade Name
Prager Shell® FDA UDI
Generic Name
Eye wash cup FDA UDI
Device Name
Sonomed, Autoclavable FDA UDI
Model / Reference
P-103GS FDA UDI
Description
Sonomed, Autoclavable FDA UDI

Identifiers

Catalog Number
P-103GS FDA UDI
Primary DI / UDI-DI
B360P103GS0 FDA UDI
510(k) Number
K082893 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Eye wash cup FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 15.7 Millimeter FDA UDI
Lumen/Inner Diameter — 14 Millimeter FDA UDI

Category: Eye wash cup

Prager Shell® by Esi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eye wash cup.

Cleared under the same submission

K082893 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Esi, Inc.

Sources (1)

  • FDA UDI d1c9447a-2dcd-44c0-89ec-d59714bfe72d 37 fields · synced May 31, 2026