DEVICE: Ureteral Catheter Administration Kit (10854913006096)

Device Identifier (DI) Information

Ureteral Catheter Administration Kit
UCAK
In Commercial Distribution
200006
UROGEN PHARMA LTD
10854913006096
GS1

1
534155213 *Terms of Use
The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The Ureteral Catheter Administration Kit contains: • Two (2) Syringe Adaptors • Two (2) Syringes, 20 mL • One (1) Ureteral Catheter, 7 Fr
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
60755 Urological surgical procedure kit, non-medicated, single-use
A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OHR Catheter Care Tray
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

409d14a2-8ad6-4a9c-81c3-97c79f3513d1
June 10, 2022
3
May 17, 2020
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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
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
1-855-987-6436
xxx@xx.xx
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