DEVICE: SureCath (05708932021500)
Device Identifier (DI) Information
SureCath
28037
In Commercial Distribution
28037
Coloplast A/S
28037
In Commercial Distribution
28037
Coloplast A/S
SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 16/5.3 mm. Vol 1200 ml.
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? |
---|---|---|---|---|
45605 | Single-administration urethral catheterization kit, single-use |
A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZD | CATHETER, STRAIGHT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K973070 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Do not use if sterile barrier is damaged |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 16 French |
Length: 40 Centimeter |
Outer Diameter: 5.3 Millimeter |
Total Volume: 1200 Milliliter |
Device Size Text, specify: Male |
Device Record Status
6f0da916-5f5c-4aac-a407-687f808970ea
July 06, 2018
3
September 02, 2016
July 06, 2018
3
September 02, 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 |
---|---|---|---|---|---|
05708932640664 | 20 | 05708932021500 | In Commercial Distribution | Retail box | |
05708932640657 | 4 | 05708932640664 | In Commercial Distribution | Shipper box |
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(800)533-0464
healthcarecs@coloplast.com
healthcarecs@coloplast.com