DEVICE: LoFric® Origo™ (07392532122583)

Device Identifier (DI) Information

LoFric® Origo™
44416
In Commercial Distribution
44416
Dentsply Ih AB
07392532122583
GS1

1
354059073 *Terms of Use
Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH16 / Coudé 16" 16FR, Sterile device.
CLOSE

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
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.
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: 16 French
Length: 16 Inch
CLOSE

Device Record Status

8baf19bc-778b-48b3-88b5-75587ed123d8
October 04, 2018
4
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
07392532154362 4 07392532154355 In Commercial Distribution Transport Packaging
07392532154355 30 07392532122583 In Commercial Distribution
07392532183195 5 07392532122583 In Commercial Distribution Customer pack
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