DEVICE: IRIS (07613327174816)

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Device Identifier (DI) Information

IRIS
0220180518
0220180518
STRYKER CORPORATION
07613327174816
GS1
1
[Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 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

[?]

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

GMDN Preferred Term Name GMDN Definition
Fibreoptic ureteral catheter, single-use A sterile, flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for illumination to enable the path of the ureter to be seen. It also includes a plug for connection to a fibreoptic light source and a port for irrigation at its proximal end. The catheter is used to aid in dissection and placement of sutures during bladder surgery and for transillumination of the ureters during laparoscopic or open lower abdominal/pelvic surgery. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FCW Light source, fiberoptic, routine
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
37613327174817 5 07613327174816 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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