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

Ear Nose & Throat › SurgicalEar, Nose, And Throat Surgical Tray

Regard™

Name: Regard™
Brand: Regard™

33 catalogue numbers from ET0638, listed by Resource Optimization & Innovation, L.L.C., under Ear, Nose, And Throat Surgical Tray. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

33catalogue 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 Regard™
Listed by	Resource Optimization & Innovation, L.L.C.
FDA product code	OGR
Device type	Ear, Nose, And Throat Surgical Tray
Device class	Class 1
Regulation	21 CFR 874.4420
Premarket notification	Exempt
Record published	2018-02-26
Record revised	2020-08-27 (version 5)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Pack of 4, pack of 3, pack of 2, pack of 10, pack of 15, pack of 5
Distribution end date	2020-08-26
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
ET0638		Withdrawn
ET0326		Withdrawn
ET0744		Withdrawn
ET0743		Withdrawn
ET0702		Withdrawn
ET0867		Withdrawn
GS1012		Withdrawn
ET0457		Withdrawn
GS0300		Withdrawn
ET0701		Withdrawn
ET0927		Withdrawn
ET0936		Withdrawn
ET0262		Withdrawn
ET0282		Withdrawn
ET0914		Withdrawn
ET0728		Withdrawn
ET1010		Withdrawn
ET0695		Withdrawn
ET0460		Withdrawn
ET1030		Withdrawn
ET0725		Withdrawn
ET0722		Withdrawn
ET0432		Withdrawn
ET0433		Withdrawn
ET0648		Withdrawn
ET0855		Withdrawn
GS0920		Withdrawn
GS0088		Withdrawn
ET0837		Withdrawn
ET1068		Withdrawn
ET0569		Withdrawn
ET1057		Withdrawn
ET0275		Withdrawn

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
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
DeRoyal	Deroyal Industries, Inc.	11
Invenio	GRI-Alleset, Inc.	8

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

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.