DEVICE: INVOcell Holding Block (00862190000327)

Device Identifier (DI) Information

INVOcell Holding Block
P-007
Not in Commercial Distribution

INVO BIOSCIENCE, INC.
00862190000327
GS1
December 31, 2018
1
829694889 *Terms of Use
The INVOcell Holding Block is used with the INVOcell Culture Device to aid in temperature maintenance of the INVOcell Culture Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Culture Device during human gamete/embryo loading and collection procedures. The INVOcell Holding Block is stainless steel with a glass-viewing window.
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Device Characteristics

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

GMDN

[?]

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?
56648 Assisted reproduction procedure dish
A container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
OYO Culture, Intravaginal, Assisted Reproduction
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN150008 000
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Sterilization

No
Yes
Sterilization Method [?]
Liquid Chemical
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store away from moisture and direct heat
Storage Environment Temperature: less than 77 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8ff15c4f-c7b6-4164-8379-636f722d89c6
February 20, 2023
6
September 23, 2016
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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