AccessGUDID - DEVICE: LoFric® Origo™ (07392532122545)

GUDID

Device Identifier (DI) Information

Brand Name: LoFric® Origo™
Version or Model: 44318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44318
Company Name: Dentsply Ih AB

Primary DI Number: 07392532122545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354059073 *Terms of Use

Device Description: Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH18 / Nelaton 16" 18FR, Sterile device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

FDA Product Code

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Product Code	Product Code Name
EZD	CATHETER, STRAIGHT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature

Clinically Relevant Size

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Size Type Text
Length: 16 Inch
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: d99b1207-15cb-498a-b396-e521979b703a
Public Version Date: October 04, 2018
Public Version Number: 4
DI Record Publish Date: January 20, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
07392532156441	4	07392532156434	In Commercial Distribution	Transport Packaging
07392532156434	30	07392532122545	In Commercial Distribution
07392532183072	5	07392532122545	In Commercial Distribution	Customer pack