DEVICE: Panthera-Puncher 9 (06438147325856)

Device Identifier (DI) Information

Panthera-Puncher 9
2081-0010
In Commercial Distribution
2081-0010
Wallac Oy
06438147325856
GS1

1
540156544 *Terms of Use
Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Panthera-Puncher 9 is cabable of handling up to 9 pcs of 96-well microtiter plates simultaneously. Panthera-Puncher contains a camera for imaging of the sample card and for blood detection.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
Yes
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No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57871 Specimen processing instrument IVD
An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.
Active false
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FDA Product Code

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Product Code Product Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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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

d7c2bb01-1e12-40d2-92c8-7e928149dff7
June 14, 2023
2
April 30, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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