FDA.reportPublic FDA data

Spotter Device (without accessories)

Primary DI
07290114352000
Brand
Spotter Device (without accessories)
Company
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Model
SPR
Catalog number
5-SPR-000
Device description
Spotter Device (without accessories)
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LNFSystem, Hyperthermia, Manual Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNFSystem, Hyperthermia, Manual Control

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290114352000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114352000072901143520007290114352000

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic metal detectorA device designed to use the fluxmeter principle to detect the presence of metal in patients, such as metal fragments in wounds requiring removal or metallic implants prior to a magnetic resonance imaging (MRI) examination.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532219235
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D1001309252002Apex File Grip (Set of 2)113092520022026-05-27
D1001309253002Apex Lip hook (Set of 2)12026-05-27
D100A102900000301PROPEX® Lip Clip1A1029000003012026-01-23
D100A102900000401PROPEX® File Clip1A1029000004012026-01-23
D100A103000000200Propex-Pixi Apex Locator1A1030000002002026-01-23
D100A103100000301Propex Pixi® Apex Locator Long measurement cable with clip1A1031000003012026-01-23
D100B00XSAL000000X-Smart Apex LocatorX-Smart ALB00XSAL0000002026-01-23
D100B00XSALAC1000X-Smart® Apex Locator Measurement cable1B00XSALAC10002026-01-23
D100B00XSALAC2000X-Smart® Apex Locator File clip1B00XSALAC20002026-01-23
D100B00XSALAC3000X-Smart® Apex Locator Lip clip1B00XSALAC30002026-01-23
D100B00XSALAC4000X-Smart® Apex Locator Touch probe1B00XSALAC40002026-01-23
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorX-Smart GoB00XSGO0000002026-01-23
D100B00XSGOAC0001X-Smart® Go Measurement cable1B00XSGOAC00012026-01-23
D100B00XSGOAC0002X-Smart® Go File clip1B00XSGOAC00022026-01-23
D100B00XSGOAC0003X-Smart® Go Lip clip1B00XSGOAC00032026-01-23
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)1B00XSGOAC00062026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeve1B00XSGOAC00072026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bank1BSPXSGOAC00052026-01-23
17290114352007Spotter Device SetSPR2024-09-18
17290114352106Spotter Demo setDemo2024-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290114352007Spotter Device SetFORUM ENGINEERING TECHNOLOGIES (96) LTD.LNF2024-09-18
17290114352106Spotter Demo setFORUM ENGINEERING TECHNOLOGIES (96) LTD.LNF2024-09-18
17290114352205Spotter Probes - Package of 2FORUM ENGINEERING TECHNOLOGIES (96) LTD.LNF2024-09-18
17290114352304Spotter Sensors - Package of 5FORUM ENGINEERING TECHNOLOGIES (96) LTD.LNF2024-09-18
17290114352908SensorsFORUM ENGINEERING TECHNOLOGIES (96) LTD.LNF2024-09-18