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

Halyard

Name: Halyard
Brand: Halyard

5 catalogue numbers from UITA72-02, listed by Avid Medical, Inc., United States, 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

5catalogue 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 Halyard
Listed by	Avid Medical, Inc., United States
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	2026-05-06

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
Storage	Special storage condition: STORE AT ROOM TEMPERATURE
Packaging	Pack of 4, pack of 8, pack of 12, pack of 27
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Halyard
Catalogue number	Size	Status
UITA72-02		In distribution
MREN03-01		In distribution
FDTA11-01		In distribution
CMTA65-01		In distribution
IHER22-01		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
DeRoyal	Deroyal Industries, Inc.	11

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.