Prager Shell® P-101
by Esi, Inc.
Prager Shell P-101 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 B360P1010), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB360P1010 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082893 | Date5 Dec 2008 | StatusActive |
Official records
- FDA 510(k) database K082893
Across registries
- FDA 510(k) K082893 decided 5 Dec 2008 Active
- FDA GUDID UDI-DI B360P1010 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K082893
- Listed FDA GUDID B360P1010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Prager Shell®
- Generic name
- Eye wash cup
- Model / Ref / Catalog
- P-101
- Primary DI / UDI-DI
- B360P1010
- 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 MillimeterLumen/Inner Diameter — 14 Millimeter
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