FDA.report

Gamma Finder® II

Primary DI
04056702002237
Brand
Gamma Finder® II
Company
W.O.M. World of Medicine GmbH
Model
GMFDR002
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IZDProbe, Uptake, Nuclear

Product Code Classifications

CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04056702002237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04056702002237040567020022374056702002237

GMDN Terms

TermDefinition
Hand-held-detector nuclear medicine systemAn assembly of diagnostic devices comprising a hand-held, non-imaging system designed primarily to detect, record, quantify and analyse various radioactive emissions (gamma, alpha, beta) of injected or ingested radiopharmaceuticals, radiation emitting devices, or other materials. It is frequently used in the monitoring and detection of deep vein thrombosis (DVT), in surgical procedures requiring radionuclide localization and in some radiolabeled monoclonal antibody applications. It often has special software or accessory features that distinguish them from similar devices used for radiation protection purposes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
316305242
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04056702012038Tube set for suction, 2-lines, single-useTS-P107-A2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2026-03-10
04056702012076Patient tube for irrigation, single-useTS-P508-A2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useTS-P501-C2026-03-10
04056702012113Tube set for suction, single-useTS-P102-H2026-03-10
04056702012137Tube set inflow 4-Spike adaptorTS-P502-A2026-03-10
04056702012861GYN-PumpPH3042024-06-28
04056702012878Fluid Monitoring UnitPS3042024-06-28
04056702008789Heating tube set for insufflation, single useINSFHTDTUB2020-11-01
04056702008802Tube set for insufflation, single-useINSFTUB2020-11-01
04056702008826Tube set for suction, single-useOTFLWTBING22020-11-01
04056702008840Tube set for suction (with 2 ports), single-useOTFLWTBING2020-11-01
04056702008864Tube set for irrigation, single-useINFLWTBING2020-11-01
04056702008888Tube set for vacuum incl. filter, 30-day useINTUBWVACC2020-11-01
04056702008895Insufflator 50LZEOSINSUFF2020-11-01
04056702008901ARTHRO-PumpZEOSINFLOW2020-11-01

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