DEVICE: Ideal Eyes (07613327059427)
Device Identifier (DI) Information
Ideal Eyes
0502539030
Not in Commercial Distribution
0502-539-030
STRYKER CORPORATION
0502539030
Not in Commercial Distribution
0502-539-030
STRYKER CORPORATION
Laparoscope, Autoclavable, Full Screen, 30 DEG View Direction.
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? |
---|---|---|---|---|
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 |
---|---|
GCJ | Laparoscope, general & plastic surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Hydrogen Peroxide |
Moist Heat or Steam Sterilization |
Ethylene Oxide |
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -18 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 5.0 Millimeter |
Device Record Status
d12c9bbf-7daa-4ea6-94bc-7a81a48ad302
March 23, 2023
5
September 23, 2016
March 23, 2023
5
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)624-4422
xx@xx.xx
xx@xx.xx