What is FDA product code OGS?

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 › ProstheticMyringotomy Procedure Kit

Medical Action Industries

Name: Medical Action Industries
Brand: Medical Action Industries

Catalogue number 77976, listed by Medical Action Industries, Inc., United States, under Myringotomy Procedure Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OGS
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Medical Action Industries
Listed by	Medical Action Industries, Inc., United States
FDA product code	OGS
Device type	Myringotomy Procedure Kit
Device class	Class 2
Regulation	21 CFR 874.3880
Premarket notification	Exempt
Record published	2018-09-10
Record revised	2022-12-01 (version 2)

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 20
Distribution end date	2022-11-30
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medical Action Industries
Catalogue number	Size	Status
77976		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	112
ACS	American Contract Systems, Inc.	4
Adept Medical	Jedmed Instrument Company	4
invenio	GRI Medical & Electronic Technology Co., Ltd.	2
BR Surgical, LLC	BR Surgical LLC	2
Halyard	Avid Medical, Inc.	1
DeRoyal	Deroyal Industries, Inc.	1

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.