Hygitech Hy-138
by Hygitech
Hygitech Hy-138 is a Class I device made by Hygitech, listed in FDA GUDID since 24 Nov 2020 (UDI-DI 03615140002783), 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 | Number03615140002783 | Date24 Nov 2020 | StatusListed |
Official records
- AccessGUDID record 03615140002783
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Hygitech
- Generic name
- Surgical gown, single-use
- Model / Ref / Catalog
- HY-138
- Primary DI / UDI-DI
- 03615140002783
- FDA product code
- FXP
- GMDN term
- Surgical gown, single-use
- Device class
- Class I
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
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- MICRO-MITT by COOPERVISION INC.
- DISPOSABLE SHOE COVERS AND NURSES CAPS by Abco Dealers, Inc.