AccessGUDID - DEVICE: LoFric® Hydro-Kit™ (07392532142673)

GUDID

Device Identifier (DI) Information

Brand Name: LoFric® Hydro-Kit™
Version or Model: 42312
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4231240
Company Name: Dentsply Ih AB

Primary DI Number: 07392532142673
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 LoFric Hydro-Kit Nelaton 8" 12FR

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":	Yes
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: 8 Inch
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: 1591e228-4827-446e-915b-3b553da9f91b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 23, 2016