DEVICE: IEC-Innoview GmbH (B192300495000)
Device Identifier (DI) Information
IEC-Innoview GmbH
30-0495-00
In Commercial Distribution
30-0495-00
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
30-0495-00
In Commercial Distribution
30-0495-00
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
5 mm, 30 deg Laparoscope, L=300 mm, autoclavable, Large View
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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12291 | Rigid optical laparoscope |
An endoscope with a rigid inserted portionangulus iridocornealis 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 by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HET | Laparoscope, Gynecologic (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K982276 | 000 |
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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Angle: 30 degree |
Length: 300 Millimeter |
Outer Diameter: 5.0 Millimeter |
Device Record Status
26042358-b495-490c-b1dc-b0d2cb1f81f9
July 06, 2018
3
May 26, 2016
July 06, 2018
3
May 26, 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 |
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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
[?]
No Customer Contact currently defined