DEVICE: Gamma Finder Sterile Sleeve (04056702004170)

Device Identifier (DI) Information

Gamma Finder Sterile Sleeve
GMSLV001-50
In Commercial Distribution

W.O.M. World of Medicine GmbH
04056702004170
GS1

1
316305242 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hand-held-detector nuclear medicine system An 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.
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FDA Product Code

[?]
Product Code Product Code Name
IZD Probe, Uptake, Nuclear
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7c3f9230-d0c3-458f-ad7b-ca4a8d50de15
March 29, 2018
2
August 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04056702004187 50 04056702004170 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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