What is FDA product code FTN?

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.

General & Plastic Surgery › ProstheticPlastic Surgery And Accessories Kit

Regard™

Name: Regard™
Brand: Regard™

5 catalogue numbers from PL0126, listed by Resource Optimization & Innovation, L.L.C., under Plastic Surgery And Accessories Kit. 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), Guangdong (1).

Chinese manufacturers registered for FDA product code FTN
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Dongguan Shin YI Healthcare Products Factory	Dong Guan	Guangdong	Contract manufacturer	30

Record

Regulatory record for Regard™
Listed by	Resource Optimization & Innovation, L.L.C.
FDA product code	FTN
Device type	Plastic Surgery And Accessories Kit
Device class	Class 1
Regulation	21 CFR 878.3925
Premarket notification	Exempt
Record published	2018-05-04
Record revised	2022-06-17 (version 5)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 2, pack of 3, pack of 4
Distribution end date	2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
PL0126		Withdrawn
PL0380		Withdrawn
PL0390		Withdrawn
PL0023		Withdrawn
ET0610		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	4,366
ACS	American Contract Systems, Inc.	109
Stradis	Stradis Healthcare	102
Henry Schein	Henry Schein, Inc.	93
Stradis Healthcare	Stradis Healthcare	81
Centurion Medical Products Corp	Medline Industries, Inc.	20
Regard™	ROi CPS LLC	13
Invenio	GRI Medical & Electronic Technology Co., Ltd.	12
Medline	Medline Industries, Inc.	5
Stradis Medical, LLC.	Stradis Healthcare	5
Invenio	GRI-Alleset, Inc.	3
Bausch and Lomb	Medline Industries, Inc.	3

Showing 12 of 19. All products under Plastic Surgery And Accessories 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.