Drape KB100 Series KB100D
Drape KB100 Series KB100D is a Class II device made by Kent Imaging Inc, listed in FDA GUDID since 10 Jul 2025 (UDI-DI B376KB100D0), registry data as of 23 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 | NumberB376KB100D0 | Date10 Jul 2025 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Drape KB100 Series
- Generic name
- Patient surgical drape, single-use
- Model / reference
- KB100D
- Primary DI / UDI-DI
- B376KB100D0
- FDA product code
- PUI
- GMDN term
- Patient surgical drape, 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 PUI (Drape, Surgical, Exempt).
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- 470015 by Intuitive Surgical, Inc.
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- Sterile-Z 5582 by TIDI Products, LLC.
- CMR 20302 by PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI
- TRAY COVER QUATERA 700 303061-9112-000 by Carl Zeiss Meditec AG
- Ion 490127 by Intuitive Surgical, Inc.
- CMR 20102 by PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI