FDA.reportPublic FDA data

SCOUT®

Primary DI
10884450500535
Brand
SCOUT®
Company
MERIT MEDICAL SYSTEMS, INC.
Model
00884450500538
Catalog number
SSR05-01/H
Published
2023-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

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
10884450500535PackageGS15In Commercial Distribution
20884450500532PackageGS116In Commercial Distribution
00884450500538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445050053510884450500535
2088445050053220884450500532
00884450500538008844505005388844505005380884450500538

GMDN Terms#

Term, Definition table
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#

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

Sterilization Methods#

Method table
Method

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03
00884450839133Prelude Roadster™APG6F65S2026-06-19
10884450114770Prelude IDeal™HPID5F11021PW2026-06-20
10884450115982Prelude IDeal™HPID7F16021PW2026-09-15
10884450118679Prelude EASE™JPHR4F7018SC2026-10-27
10884450438517Prelude® PROJPRO-7F-11-035MT2026-09-15
10884450438586Prelude® PROJPRO-8F-11-035MT2026-09-15
10884450439439Prelude IDeal™JPID4F7018NTPD2026-09-01
10884450451141Prelude SNAP™DPLS-10072026-09-12
10884450451783Prelude SNAP™DPLS-10062026-09-12
10884450451790Prelude SNAP™DPLS-1008.52026-09-12
10884450451806Prelude SNAP™DPLS-10082026-09-12
10884450451813Prelude SNAP™DPLS-1009.52026-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817295021166InradInradNEU2026-10-08
00817295021197InradInradNEU2026-10-08
00817295021401InradInradNEU2026-10-08
00817295021418InradInradNEU2026-10-08
00817295021425InradInradNEU2026-10-08
00884450554883SCOUT®MERIT MEDICAL SYSTEMS, INC.NEU2026-10-07
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