DEVICE: LoFric® Origo™ (07392532122552)
Device Identifier (DI) Information
LoFric® Origo™
44410
Not in Commercial Distribution
4441040
Wellspect AB
44410
Not in Commercial Distribution
4441040
Wellspect AB
Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH10 / Coudé 16" 10FR, Sterile device.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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 [?] |
---|---|
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 |
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Length: 16 Inch |
Catheter Gauge: 10 French |
Device Record Status
01f852c4-5420-43c6-b315-411308bba546
September 26, 2023
8
November 23, 2016
September 26, 2023
8
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 |
---|---|---|---|---|---|
07392532154270 | 4 | 07392532154263 | 2023-09-25 | Not in Commercial Distribution | |
07392532154263 | 30 | 07392532122552 | 2023-09-25 | Not in Commercial Distribution | |
07392532183102 | 5 | 07392532122552 | 2023-09-25 | Not 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