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.

Stradis · Plastic Surgery and Accessories Kit → General & Plastic Surgery

Name: Stradis
Brand: Stradis

2manufacturers in China registered for this device type

102catalogue 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 Stradis
Listed by	Stradis Healthcare, United States
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	2017-01-02
Record revised	2022-06-17 (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	Contains natural rubber latex
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Packaging	Pack of 4, pack of 5, pack of 50
Distribution end date	2023-02-07

Catalogue Numbers

Catalogue numbers for Stradis
Catalogue number	Size	Status
681-277		In distribution
693-223		In distribution
570-3071		In distribution
681-263		In distribution
693-094		In distribution
693-260		In distribution
681-276		In distribution
693-117		In distribution
693-162		In distribution
681-261		In distribution
693-108		In distribution
681-508		In distribution
693-088		In distribution
694-015		In distribution
693-216		In distribution
570-3070		In distribution
570-3064		In distribution
681-264		In distribution
693-126		In distribution
693-196		In distribution
681-258		In distribution
693-259		In distribution
681-234		In distribution
681-342		In distribution
694-002		In distribution
693-239		In distribution
694-001		In distribution
681-249		In distribution
693-088		Withdrawn
681-502		Withdrawn
694-009		Withdrawn
693-280		Withdrawn
570-3117		Withdrawn
693-236		Withdrawn
570-3119		Withdrawn
681-265		Withdrawn
693-239		Withdrawn
681-256		Withdrawn
681-282		Withdrawn
693-210		Withdrawn
681-291		Withdrawn
681-295		Withdrawn
681-506R2		Withdrawn
570-3093		Withdrawn
681-501R1		Withdrawn
681-501		Withdrawn
681-228		Withdrawn
693-280		Withdrawn
570-3148		Withdrawn
693-099		Withdrawn
681-299		Withdrawn
681-271		Withdrawn
682-1228		Withdrawn
570-3149		Withdrawn
693-003		Withdrawn
681-503		Withdrawn
681-254		Withdrawn
681-506		Withdrawn
570-3147		Withdrawn
693-219		Withdrawn
681-256		Withdrawn
681-298		Withdrawn
681-248		Withdrawn
681-227		Withdrawn
693-222		Withdrawn
681-022A		Withdrawn
609-009		Withdrawn
693-189		Withdrawn
681-002		Withdrawn
694-003		Withdrawn
681-277		Withdrawn
688-057		Withdrawn
681-273		Withdrawn
681-272		Withdrawn
693-210		Withdrawn
681-319		Withdrawn
693-199		Withdrawn
694-007		Withdrawn
670-249		Withdrawn
693-147		Withdrawn
693-272		Withdrawn
681-248		Withdrawn
693-118		Withdrawn
681-503		Withdrawn
681-319		Withdrawn
693-236		Withdrawn
681-022		Withdrawn
570-3118		Withdrawn
525-181		Withdrawn
681-022A		Withdrawn
693-125		Withdrawn
570-3150		Withdrawn
693-167		Withdrawn
681-288		Withdrawn
693-265		Withdrawn
693-166		Withdrawn
681-001		Withdrawn
693-203		Withdrawn
690-253		Withdrawn
570-3151		Withdrawn
693-116		Withdrawn
681-228		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
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
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 Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Stradis
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stradis Medical, LLC dba Stradis Healthcare	UDI-DI	2022-11-02	Class II	Packaging process control	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.	328 units
Stradis Medical, LLC dba Stradis Healthcare	UDI-DI	2022-11-02	Class II	Packaging process control	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.	6 units

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.

Stradis