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.

Regard™ · Plastic Surgery and Accessories Kit → General & Plastic Surgery

Name: Regard™
Brand: Regard™

2manufacturers in China registered for this device type

13catalogue numbers in this listing

1recall

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	ROi CPS LLC
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	2020-01-03
Record revised	2025-06-05 (version 5)

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
Packaging	Pack of 2, pack of 4, pack of 3
Distribution end date	2026-01-13

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
PL00390F		Withdrawn
PL00023O		Withdrawn
PL00023N		Withdrawn
PL00023P		Withdrawn
PL00126ST		Withdrawn
PL00380G		Withdrawn
PL00126R		Withdrawn
PL00126S		Withdrawn
PL00390G		Withdrawn
PL00380H		Withdrawn
PL00390H		Withdrawn
PL00126T		Withdrawn
PL00126U		Withdrawn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
Invenio	GRI Medical & Electronic Technology Co., Ltd.	12
Medline	Medline Industries, Inc.	5
Regard™	Resource Optimization & Innovation, L.L.C.	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

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-04-20	Class II	Other	Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.	40 Kits.	2020-08-21

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.

Regard™