What is FDA product code OXQ?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Stradis Medical, LLC. · Dressing Change Tray → General Hospital

Name: Stradis Medical, LLC.
Brand: Stradis Medical, LLC.

1manufacturer

6catalogue numbers in this listing

1recall

Who Else Makes It

Registered in Hubei.

Chinese manufacturers registered for FDA product code OXQ
Manufacturer	City	Province	Registered as	Device types
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33

Record

Regulatory record for Stradis Medical, LLC.
Listed by	Stradis Healthcare, United States
FDA product code	OXQ
Device type	Dressing Change Tray
Device class	Class 1
Regulation	21 CFR 880.5075
Record published	2017-12-12
Record revised	2023-02-10 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Outer box of 30, outer box of 20
Distribution end date	2023-02-09

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC.
Catalogue number	Size	Status
HCT9958CP		In distribution
MSDC-010956		In distribution
HHSBRF-661		In distribution
IM1231E		In distribution
DC-17686TM		Withdrawn
HCT9958CP-1		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	3,005
Medline	Medline Industries, Inc.	1,428
Centurion	Centurion Medical Products Corporation	1,319
Medline Industries, Inc.	Medline Industries, Inc.	218
MedStream	Medical Specialties Distributors, Inc.	202
Vygon	Vygon Corp.	112
LSL Healthcare	Lsl Industries, Inc.	75
Centurion Medical Products Corp	Medline Industries, Inc.	45
ACS	American Contract Systems, Inc.	35
Medline	Centurion Medical Products Corporation	34
Trinity Sterile, Inc.	Trinity Sterile, Inc.	31
DeRoyal	Deroyal Industries, Inc.	15

Showing 12 of 30. All products under Dressing Change Tray

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2022-05-10	Class II	Other	Potential for incomplete seals.	520 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Stradis Medical, LLC.