DEVICE: LoFric® (07392532131769)

Device Identifier (DI) Information

LoFric®
40210
In Commercial Distribution
4021040
Dentsply Ih AB
07392532131769
GS1

1
354059073 *Terms of Use
Single Use Urinary Catheter LoFric Nelaton 12" 10FR Paediatric
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EZD CATHETER, STRAIGHT
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 10 French
Length: 12 Inch
CLOSE

Device Record Status

f5df87a9-60b7-4d06-acba-1cbb1cd2c269
March 29, 2018
2
November 23, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07392532097393 4 07392532097386 In Commercial Distribution Transport Packaging
07392532097386 30 07392532131769 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)456-3742
info-lofric-usa@wellspect.com
CLOSE