What is FDA product code OGE?

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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Anesthesiology › TherapeuticEpidural Anesthesia Kit

Stradis Healthcare

Name: Stradis Healthcare
Brand: Stradis Healthcare

5 catalogue numbers from 570-1081, listed by Stradis Healthcare, United States, under Epidural Anesthesia Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

5catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OGE
Manufacturer	City	Province	Registered as	Device types
Zhejiang Runqiang Medical Instruments Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	9

Record

Regulatory record for Stradis Healthcare
Listed by	Stradis Healthcare, United States
FDA product code	OGE
Device type	Epidural Anesthesia Kit
Device class	Class 2
Regulation	21 CFR 868.5120
Premarket notification	Exempt
Record published	2022-03-15
Record revised	2023-01-30 (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
Distribution end date	2023-02-06

Catalogue Numbers

Catalogue numbers for Stradis Healthcare
Catalogue number	Size	Status
570-1081		Withdrawn
570-2691		Withdrawn
570-2557		Withdrawn
570-2735		Withdrawn
570-2735		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	1,319
Medline Industries, Inc.	Medline Industries, Inc.	504
Design Options®	B. Braun Medical Inc.	361
Perifix®	B. Braun Medical Inc.	118
Aligned Medical Solutions	Aligned Medical Solutions	77
Arrow	Teleflex Medical LLC	15
Epidural Anesthesia Kit Clint Pharmaceuticals	CHS USA Incorporated	11
Epidural Anesthesia Kit	Pajunk Medical Systems, LP	11
Epidural Anesthesia Kit	Custom Interventional Pain Management	10
ACS	American Contract Systems, Inc.	8
Medline	Medline Industries, Inc.	4
Epidural Anesthesia Kit	CHS USA Incorporated	4

Showing 12 of 18. All products under Epidural Anesthesia Kit

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.