DEVICE: Silber (00827002152847)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
47993 | Epididymal fluid aspiration catheter |
A flexible tube designed for the surgical aspiration of epididymal fluid during sperm extraction procedures such as microepididymal sperm aspiration (MESA), percutaneous epididymal sperm aspiration (PESA), and during open testicular procedures. It is typically made of plastic materials [e.g., polyethylene (PE), polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane, or silicone] and is available in various lengths. The aspirate is processed for assisted reproductive technology (ART) procedures such as intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FAP | CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in dark, dry, cool place. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
631566c2-1363-427d-b03d-4333964d9847
March 10, 2021
3
September 24, 2016
March 10, 2021
3
September 24, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(812)330-5494
sharedservices@cookmedical.com
sharedservices@cookmedical.com