FDA.report

Gamma Finder Sterile Sleeve

Primary DI
04056702004170
Brand
Gamma Finder Sterile Sleeve
Company
W.O.M. World of Medicine GmbH
Model
GMSLV001-50
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
true
Single use
true

Related Records

Product Codes

CodeName
IZDProbe, Uptake, Nuclear

Product Code Classifications

CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04056702004187PackageGS150In Commercial Distribution
04056702004170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04056702004187040567020041874056702004187
04056702004170040567020041704056702004170

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

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04056702012137Tube set inflow 4-Spike adaptorTS-P502-A2026-03-10
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04056702008888Tube set for vacuum incl. filter, 30-day useINTUBWVACC2020-11-01
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