DEVICE: 60X15 IVF PETRID NONTREATED VENTS (05713311000021)

Device Identifier (DI) Information

60X15 IVF PETRID NONTREATED VENTS
150270
In Commercial Distribution
150270
Nunc A/S
05713311000021
GS1

400
305971764 *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
Yes

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 procedure dish A sterile container intended 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. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MQK Labware, Assisted Reproduction
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070047 000
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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

c4571076-0520-48a9-8172-df8e51ecc98c
July 06, 2018
3
September 01, 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: 15713311000028 CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4546312000
info.nunc@thermofisher.com
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