DEVICE: ULTRASOFT FRYDMAN® SET MOCK ECHO (03700111400221)

Device Identifier (DI) Information

ULTRASOFT FRYDMAN® SET MOCK ECHO
ULTRASOFT FRYDMAN® SET MOCK ECHO
In Commercial Distribution
1323801
LABORATOIRE CCD
03700111400221
GS1

1
381633924 *Terms of Use
02 pieces sets for embryo transfer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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?
30882 Assisted reproduction transfer catheter trial
A flexible polymer tube intended to be used to simulate the transvaginal insertion of an assisted reproduction catheter set for embryo transfer, to assess advancement through the cervical canal and the position of the uterus. It typically consists of an inner and outer catheter (or catheter sheath) identical to the devices used for the transfer procedure, except that the inner catheter has a rounded blind/closed distal end. This device cannot be used for the introduction of embryos or other reproductive materials into the cervical canal or uterine cavity. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQF CATHETER, ASSISTED REPRODUCTION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.155 Centimeter
Catheter Length: 26 Centimeter
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Device Record Status

02220905-b1d2-4940-bd37-451524b63aa4
December 13, 2023
1
December 05, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
03700111425224 10 03700111400221 In Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+33(0)344266355
Infomed@ccdlab.com
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