DEVICE: Gimmi (04049047042884)
Device Identifier (DI) Information
Gimmi
E.8290.11
In Commercial Distribution
E.8290.11
Gimmi GmbH
E.8290.11
In Commercial Distribution
E.8290.11
Gimmi GmbH
LAPAROSCOPE 10 MM 0° AUTOCLAVABLE
ALPHASCOPE II WORKING LENGTH 330 MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Flexible fibreoptic laparoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle. The abdominal wall is distended, typically using a gas distention device, providing space to allow the surgeon to directly view and/or operate on the exposed organs. It is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and to perform female sterilization. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCJ | Laparoscope, general & plastic surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b524f639-ad33-4a1f-adb5-cb2c5f965172
March 29, 2018
2
May 05, 2017
March 29, 2018
2
May 05, 2017
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 |
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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
[?]
+497461965900
contact@gimmi.de
contact@gimmi.de