DEVICE: Centrifuge Tube 15 mL (17350025914593)

Device Identifier (DI) Information

Centrifuge Tube 15 mL
16105
In Commercial Distribution

Hertart ApS
17350025914593
GS1

20
305164017 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Assisted reproduction centrifuge tube A sterile container (a dedicated sealable centrifuge tube) intended for the preparation, centrifuging and storage of biological samples used in assisted reproduction techniques (ART), e.g., sperm. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF). Its main application being the separation of unwanted biological material of human origin, e.g., by adding semen and a gradient to the biological material in the tube and applying centrifugation, this facilitates the removal of seminal plasma, dead sperm and other cells; spermatozoa of highest mobility can be thus selected. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
PUD Labware, Assisted Reproduction, Exempt
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FDA Premarket Submission

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

Sterilization

Yes
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

43f264d1-4002-4c4b-a771-5d3b1ed837f1
June 08, 2020
1
May 29, 2020
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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
27350025914590 24 17350025914593 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: 07350025914596 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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