DEVICE: PIPELINE (10705034220345)
Device Identifier (DI) Information
PIPELINE
288201021
In Commercial Distribution
288201021
Medos International Sàrl
288201021
In Commercial Distribution
288201021
Medos International Sàrl
PIPELINE ACCESS SYSTEM 5TH DILATOR 21mm
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? |
---|---|---|---|---|
37151 | Laparoscopic access cannula dilator |
A hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZT | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K992898 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d84c6905-3905-46a4-98c8-e8cc12d6c7b8
February 12, 2024
4
June 30, 2016
February 12, 2024
4
June 30, 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(800)255-2500
xx@xx.xx
xx@xx.xx