What is FDA product code OHD?

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.

Upsylon™ Y Mesh Kit · Gynecological Laparoscopic Kit → Obstetrics & Gynecology

Name: Upsylon™ Y Mesh Kit
Brand: Upsylon™ Y Mesh Kit

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Zhejiang.

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

Record

Regulatory record for Upsylon™ Y Mesh Kit
Listed by	Boston Scientific Corporation, United States
FDA product code	OHD
Device type	Gynecological Laparoscopic Kit
Device class	Class 2
Regulation	21 CFR 884.1720
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2015-09-24
Record revised	2018-03-29 (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
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Upsylon™ Y Mesh Kit
Catalogue number	Size	Status
M0068318220		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	16,238
Medline Industries, Inc.	Medline Industries, Inc.	6,429
ACS	American Contract Systems, Inc.	739
Aligned Medical Solutions	Aligned Medical Solutions	112
Regard™	ROi CPS LLC	71
DeRoyal	Deroyal Industries, Inc.	42
Regard™	Resource Optimization & Innovation, L.L.C.	26
Invenio	GRI Medical & Electronic Technology Co., Ltd.	15
BR Surgical, LLC	BR Surgical LLC	15
Medical Action Industries	Medical Action Industries, Inc.	13
Medline	Medline Industries, Inc.	11
Halyard	Avid Medical, Inc.	7

Showing 12 of 14. All products under Gynecological Laparoscopic Kit

Recalls Naming This Product

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

Recalls naming the identifiers of Upsylon™ Y Mesh Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Boston Scientific Corporation	UDI-DI	2021-04-15	Class II	Packaging process control	Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection	8,524 WW

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.

Upsylon™ Y Mesh Kit