Who else makes this device?

Name: Scout Check®
Brand: Scout Check®

General & Plastic Surgery › SurgicalMarker, Radiographic, Implantable

Scout Check®

Catalogue number 00884450434468, listed by Merit Medical Systems, Inc., United States, under Marker, Radiographic, Implantable. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code NEU
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Scout Check®
Listed by	Merit Medical Systems, Inc., United States
FDA product code	NEU
Device type	Marker, Radiographic, Implantable
Device class	Class 2
Regulation	21 CFR 878.4300
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2021-09-24
Record revised	2023-09-18 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Scout Check®
Catalogue number	Size	Status
00884450434468		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HydroMARK	Devicor Medical Products, Inc.	75
Scout®	Merit Medical Systems, Inc.	68
Scout MD™	Merit Medical Systems, Inc.	46
SmartClip	Elucent Medical Inc.	37
BiomarC®	Carbon Medical Technologies, Inc.	25
HydroMARK Breast Biopsy Site Marker	Devicor Medical Products, Inc.	21
SecurMark	Hologic, Inc.	15
Gold Marker	Riverpoint Medical LLC	15
MammoStar™	Carbon Medical Technologies, Inc.	15
SecurMark for Atec	Hologic, Inc.	15
SenoMark® Ultra Breast Tissue Marker	Bard Peripheral Vascular, Inc.	14
TriMark	Hologic, Inc.	14

Showing 12 of 96. All products under Marker, Radiographic, Implantable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252892	2025-12-19
K212882	2022-04-08

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.