FDA.report

SCOUT Bx™

Primary DI
20884450719590
Brand
SCOUT Bx™
Company
Merit Medical Systems, Inc.
Model
00884450719596
Catalog number
SSR13B-01/B
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NEUMARKER, RADIOGRAPHIC, IMPLANTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450719593PackageGS15In Commercial Distribution
20884450719590PackageGS14In Commercial Distribution
00884450719596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445071959310884450719593
2088445071959020884450719590
00884450719596008844507195968844507195960884450719596

GMDN Terms

TermDefinition
Electromagnetic surgical navigation device tracking systemAn assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00884450392898SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-23
00884450392904SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-23
00884450392911SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-23
00884450393383SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-23
00884450399965SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-23
10841911102936HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103110HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00851674008577SmartClipElucent Medical, Inc.NEU2026-02-16
00851674008584SmartClipElucent Medical, Inc.NEU2026-02-16
00851674008591SmartClipElucent Medical, Inc.NEU2026-02-16
00851674008607SmartClip SecureElucent Medical, Inc.NEU2026-02-16
20884450104075SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-06
20884450104082SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-06
20884450104198SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-06
10884450104603SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-05
10884450104634SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-05
20884450104662SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-05
10884450104849SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-05
10884450104863SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-05
10884450104900SCOUT MD™MERIT MEDICAL SYSTEMS, INC.NEU2026-02-05
20884450719576SCOUT®MERIT MEDICAL SYSTEMS, INC.NEU2026-01-03
10841911103551HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
10841911103568HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
10841911103575HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
10841911103520HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
10841911103544HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00863593000266Nova ZC4 IMAGING, LLCNEU2025-10-06
00863593000280Nova ZC4 IMAGING, LLCNEU2025-10-06
00863593000297Nova ZC4 IMAGING, LLCNEU2025-10-06
14250195612165Tumark EyeSOMATEX Medical Technologies GmbHNEU2025-07-15