DEVICE: InfraVision (07613327061215)

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Device Identifier (DI) Information

InfraVision
0220180517
0220180517
STRYKER CORPORATION
07613327061215
GS1
1
[Universal Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 200 cm Length, Do not use if package is damaged]
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
General-purpose ureteral catheter A flexible tube designed for introduction into the ureters through a cystoscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double lumen and graduated markings. The device is mostly used for ureter dilation, bypass of partial obstructions, upper urinary tract drainage/irrigation during surgery, stone removal, or for retrograde urography (to enable visualization of the intrarenal collecting structures, the renal pelvis, and the ureters), guidewire placement, and brush biopsy. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FCS Light, catheter, fiberoptic, glass, ureteral
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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
37613327061216 5 07613327061215 In Commercial Distribution pack
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)624-4422
xx@xx.xx
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