Who else makes this device?

Name: Tabotamp Fibrillar
Brand: Tabotamp Fibrillar

General & Plastic Surgery › SurgicalAgent, Absorbable Hemostatic, Non-Collagen Based

Tabotamp Fibrillar

Catalogue number 431963, listed by Ethicon, Inc., United States, under Agent, Absorbable Hemostatic, Non-Collagen Based. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

2recalls on this code

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LMG
Manufacturer	City	Province	Registered as	Device types
Beijing Huan QIU LI Kang Biotech Co., Ltd.	Beijing	Beijing	Contract manufacturer	2
Sterigenics Shanghai E Beam Ltd.	Shanghai	Shanghai	Contract manufacturer	14

Record

Regulatory record for Tabotamp Fibrillar
Listed by	Ethicon, Inc., United States
FDA product code	LMG
Device type	Agent, Absorbable Hemostatic, Non-Collagen Based
Device class	Class 3
Regulation	21 CFR 878.4490
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
510(k)	N12159
Record published	2014-09-20
Record revised	2019-08-09 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C; Special storage condition: Do not use if package is damaged; Special storage condition: Do Not Resterilize
Packaging	Case of 10
Distribution end date	2015-06-23

Catalogue Numbers

Catalogue numbers for Tabotamp Fibrillar
Catalogue number	Size	Status
431963		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Surgicel	Ethicon Sàrl	8
Surgicel NU-Knit	Ethicon Sàrl	6
Surgicel SNoW	Ethicon, Inc.	6
Arista	Davol Inc.	6
Surgicel Fibrillar	Ethicon, Inc.	5
PerClot	Baxter Healthcare Corporation	5
Emergency Medical Products	Emergency Medical Products, Inc.	3
Veriset	Covidien LP	3
Surgicel Fibrillar	Ethicon Sàrl	3
Surgicel	Ethicon, Inc.	1
Ethicon	Ethicon, Inc.	1

Recalls

2 of these are 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
2024-06-11	Class II	Process control	Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.	450,793 units (65,950 US, 384,843 OUS)
2024-06-11	Class II	Process control	Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.	39,010 units (All US)

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P210036	2023-05-19	PerClot® Polysaccharide Hemostatic System	Baxter Healthcare Corporation
N12159	2023-04-04	SURGICEL® Absorbable Hemostats (SURGICEL® POWDER)	Ethicon, Inc.
P050038	2012-03-23	ARISTA AH ABSORBABLE HEMOSTAT	Davol Inc.
N5798	1991-02-08	OXYCELL	Bd Becton Dickinson Vacutainer Systems Preanalytic

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.