Hygitech Hy-523
by Hygitech
Hygitech Hy-523 is a Class II device made by Hygitech, listed in FDA GUDID since 25 Nov 2020 (UDI-DI 03615140003537), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03615140003537 | Date25 Nov 2020 | StatusListed |
Official records
- AccessGUDID record 03615140003537
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Hygitech
- Generic name
- Surgical dressing/drape kit, single-use
- Model / Ref / Catalog
- HY-523
- Primary DI / UDI-DI
- 03615140003537
- FDA product code
- KKX
- GMDN term
- Surgical dressing/drape kit, single-use
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KKX (Drape, Surgical).
- DISPOSABLE SURGICAL DRAPES AND ACCESSORIES by Medical Concepts Development, Inc.
- TOWEL, DRAPE, BOUNDARY by PROCTER & GAMBLE CO.
- DELTA-NET by Johnson & Johnson Professionals, Inc.
- BARRIER & FACE MASK WITH INNER FACING by Surgikos, Inc.
- OPMI® Drapes sterile 306025-0000-000 by Carl Zeiss Meditec AG
- SHEETS by Lancaster County Assoc. For the Blind
- HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES by Haywood Vocational Opportunities Inc.
- SPLATTER CONTROL SHIELD by Taut, Inc.
- BARRIER APERTURED DRAPE by Surgikos, Inc.
- HALE SUN SURGICAL TOWEL OR O.R. TOWEL by Hale Sun Industries, Ltd.