What is FDA product code OGR?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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

DeRoyal · Ear, Nose, and Throat Surgical Tray → Ear Nose & Throat

Name: DeRoyal
Brand: DeRoyal

2manufacturers in China registered for this device type

11catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OGR
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for DeRoyal
Listed by	Deroyal Industries, Inc., United States
FDA product code	OGR
Device type	Ear, Nose, And Throat Surgical Tray
Device class	Class 1
Regulation	21 CFR 874.4420
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2021-07-09

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	Case of 6, case of 24, case of 14, case of 12, case of 20, case of 8
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number	Size	Status
89-9296		In distribution
89-9329		In distribution
89-9340		In distribution
89-10062		In distribution
89-9812		In distribution
89-7208		In distribution
89-8461		In distribution
89-10698		In distribution
89-9424		In distribution
89-10983		In distribution
89-9886		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	16,169
Medline Industries, Inc.	Medline Industries, Inc.	8,277
ACS	American Contract Systems, Inc.	472
Centurion	Centurion Medical Products Corporation	124
Regard™	ROi CPS LLC	76
Aligned Medical Solutions	Aligned Medical Solutions	75
Regard™	Resource Optimization & Innovation, L.L.C.	33
Centurion Medical Products Corp	Medline Industries, Inc.	22
Stradis Healthcare	Stradis Healthcare	15
Integra® MicroFrance®	Integra LifeSciences Production Corporation	14
Invenio	GRI Medical & Electronic Technology Co., Ltd.	14
Invenio	GRI-Alleset, Inc.	8

Showing 12 of 23. All products under Ear, Nose, And Throat Surgical Tray

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of DeRoyal
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Deroyal Industries, Inc.	UDI-DI	2022-11-28	Class II	Nonconforming Material/Component	DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affe	320 units	2026-03-18

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.

DeRoyal