DEVICE: Follicle Aspiration Set, Single Lumen (07350025914855)
Device Identifier (DI) Information
Follicle Aspiration Set, Single Lumen
14183
In Commercial Distribution
Vitrolife Sweden AB
14183
In Commercial Distribution
Vitrolife Sweden AB
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
IVF oocyte aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQE | Needle, Assisted Reproduction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K991273 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d5f405e7-1bbe-4c28-9e5d-bc2a1f2feded
July 06, 2018
3
September 09, 2016
July 06, 2018
3
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
17350025914852 | 10 | 07350025914855 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined