DEVICE: LoFric® (07392532131752)
Device Identifier (DI) Information
LoFric®
40510
In Commercial Distribution
4051040
Dentsply Ih AB
40510
In Commercial Distribution
4051040
Dentsply Ih AB
Single Use Urinary Catheter LoFric Coudé 16" 10FR
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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 |
---|---|
Single-administration urethral drainage catheter | A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZD | CATHETER, STRAIGHT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a dry place at room temperature. |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 16 Inch |
Catheter Gauge: 10 French |
Device Record Status
4ea95bdd-400a-4517-9dc5-5f6cb218ae12
March 29, 2018
2
November 23, 2016
March 29, 2018
2
November 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 |
---|---|---|---|---|---|
07392532150357 | 4 | 07392532150340 | In Commercial Distribution | Transport Packaging | |
07392532150340 | 30 | 07392532131752 | In Commercial Distribution |
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(877)456-3742
info-lofric-usa@wellspect.com
info-lofric-usa@wellspect.com