DEVICE: IEC-Innoview GmbH (B192300427000)

Device Identifier (DI) Information

IEC-Innoview GmbH
30-0427-00
In Commercial Distribution
30-0427-00
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
B192300427000
HIBCC

1
010741028 *Terms of Use
10 mm, 0 deg Laparoscope, L=339 mm, autoclavable, Laser welded
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
HET Laparoscope, Gynecologic (And Accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K982276 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 10.0 Millimeter
Length: 339 Millimeter
Angle: 0 degree
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Device Record Status

89d42e73-89c6-436a-b4ce-8fc489db02cd
July 06, 2018
3
May 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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