DEVICE: n.a. (04048551358894)
Device Identifier (DI) Information
n.a.
26031SO
In Commercial Distribution
Karl Storz GmbH & Co. KG
26031SO
In Commercial Distribution
Karl Storz GmbH & Co. KG
2 Tissue Retractors, s-shaped
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? |
---|---|---|---|---|
36302 | Laparoscopic mechanical-distention system |
An assembly of mechanical devices intended to be used to create a space in the abdominal cavity for laparoscopic procedures by externally lifting the abdominal wall. This isobaric method of lifting the abdominal wall includes the insertion of a retractor, sling, subcutaneous wires or needles and an external lifting mechanism consisting of, e.g., a manual traction device, a support arm clamped to the operating table, or a winch and framework. This device requires no, or minimal, gas insufflation. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K946359 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
65dbbf9a-e70e-4ddd-89db-d5a2f604869c
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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:
04048551091579
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined