Medichoice ORT02BX
by Owens & Minor Distribution, Inc.
Medichoice ORT02BX is a surgical towel (FDA Class II; FDA product code KKX, Drape, surgical) made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K001858 on 17 Aug 2000 and listed in FDA GUDID since 20 Aug 2016 (UDI-DI 10885632131677), 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 | Number10885632131677 | Date20 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK001858 | Date17 Aug 2000 | StatusActive |
Official records
- AccessGUDID record 10885632131677
- FDA 510(k) database K001858
Across registries
- FDA 510(k) K001858 decided 17 Aug 2000 Active
- FDA GUDID UDI-DI 10885632131677 listed 20 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K001858
- Listed FDA GUDID 10885632131677
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medichoice
- Generic name
- Surgical towel
- Model / reference
- ORT02BX
- Primary DI / UDI-DI
- 10885632131677
- 510(k) Number
- FDA product code
- KKX
- GMDN term
- Surgical towel
- 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).
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- WHITE KNIGHT BOVIE CORD/SUCTION TUBE by G.D. Searle and Co.
- BARRIER* OVERHEAD TABLE DRAPE by Surgikos, Inc.
- OR TOWEL by Hermitage Hospital Products, Inc.
- OPMI® Drapes 326044-0000-000 by Carl Zeiss Meditec AG
- SURGICAL DRAPES AND DRAPE ACCESSORIES by Avery Intl.
- STERILE SURGICAL DRAPES AND SHEETS by Clinitech, Inc.