FDA.reportPublic FDA data

SCOUT®

Primary DI
00884450435748
Brand
SCOUT®
Company
MERIT MEDICAL SYSTEMS, INC.
Model
M
Catalog number
SG-01
Published
2026-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NEUMARKER, RADIOGRAPHIC, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450435748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450435748008844504357488844504357480884450435748

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation/tracking systemAn assembly of devices intended for tracking spatial markers attached to a surgical instrument(s) and/or the patient, based on movement through a variable electromagnetic (EM) field. It is designed to generate visual diagrams of the relative position/orientation of the instrument/marker during surgery and may additionally allow surgical navigation through overlay of radiological images [e.g., ultrasound (US)]. It consists of a console with display and an EM field generator/receiver; spatial markers, instruments, a foot switch, or trolley may in addition be packaged with the system. It is intended for use during multiple types of surgical procedure (e.g., breast, gastrointestinal, lung).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
117056277
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103653HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2026-07-07
00841911102939HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103110HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103554HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103561HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103578HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103523HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103547HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103479HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103486HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103493HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103509HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103516HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103370HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103387HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103394HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103400HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103417HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103424HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103431HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103448HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103455HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103462HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103318HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103325HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103332HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103349HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103356HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103363HydroMarkDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01