DEVICE: NA (07613327063592)
Device Identifier (DI) Information
NA
0502880430
In Commercial Distribution
0502-880-430
STRYKER CORPORATION
0502880430
In Commercial Distribution
0502-880-430
STRYKER CORPORATION
6.9/10 Fr. SRU-6X, Semi-Rigid Ureteroscope, Autoclavable
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
36654 | Rigid optical ureteroscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FGB | Ureteroscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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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Length: 43.0 Centimeter |
Device Record Status
f433cb7c-465b-4135-ad7c-a9c45e525f38
November 17, 2023
3
September 23, 2016
November 17, 2023
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 |
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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
[?]
+1(866)624-4422
xx@xx.xx
xx@xx.xx