SimPro™ Core 5431800

GUDID 07392532194368

Single Use Urinary Catheter with water sachet. Female Nelaton 8" 18FR

Dentsply Ih AB

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 07392532194368
• NIH Device Record Key: 09125c3c-11d2-4588-9fa4-ce2ded912529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimPro™ Core
• Version Model Number: 5431800
• Catalog Number: 5431800
• Company DUNS: 354059073
• Company Name: Dentsply Ih AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com
• Phone: +1(877)456-3742
• Email: info-lofric-usa@wellspect.com

Device Dimensions

• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French
• Length: 8 Inch
• Catheter Gauge: 18 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07392532194351 [Primary]
GS1	07392532194368 [Package]; Contains: 07392532194351; Package: Customer Packaging [30 Units]; In Commercial Distribution
GS1	07392532194375 [Package]; Package: Transport Packaging [4 Units]; In Commercial Distribution

FDA Product Code

• EZD: CATHETER, STRAIGHT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-26

On-Brand Devices [SimPro™ Core]

• 07392532194917: Single Use Urinary Catheter with water sachet. Tiemann 16" 20FR
• 07392532194870: Single Use Urinary Catheter with water sachet. Tiemann 16" 18FR
• 07392532194849: Single Use Urinary Catheter with water sachet. Tiemann 16" 16FR
• 07392532194818: Single Use Urinary Catheter with water sachet. Tiemann 16" 14FR
• 07392532194795: Single Use Urinary Catheter with water sachet. Tiemann 16" 12FR
• 07392532194764: Single Use Urinary Catheter with water sachet. Tiemann 16" 10FR
• 07392532194733: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 24FR
• 07392532194696: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 22FR
• 07392532194665: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 20FR
• 07392532194634: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 18FR
• 07392532194603: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 16FR
• 07392532194580: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 14FR
• 07392532194559: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 12FR
• 07392532194528: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 10FR
• 07392532194498: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 08FR
• 07392532194450: Single Use Urinary Catheter with water sachet. Pediatric Nelaton 12" 10FR
• 07392532194436: Single Use Urinary Catheter with water sachet. Pediatric Nelaton 12" 08FR
• 07392532194399: Single Use Urinary Catheter with water sachet. Pediatric Nelaton 12" 06FR
• 07392532194368: Single Use Urinary Catheter with water sachet. Female Nelaton 8" 18FR
• 07392532194344: Single Use Urinary Catheter with water sachet. Female Nelaton 8" 16FR
• 07392532194306: Single Use Urinary Catheter with water sachet. Female Nelaton 8" 14FR
• 07392532194276: Single Use Urinary Catheter with water sachet. Female Nelaton 8" 12FR
• 07392532194245: Single Use Urinary Catheter with water sachet. Fem/Ped Nelaton 8" 10FR
• 07392532194214: Single Use Urinary Catheter with water sachet. Fem/Ped Nelaton 8" 08FR
• 07392532194184: Single Use Urinary Catheter with water sachet. Pediatric Nelaton 8" 06FR
• 07392532194160: Single Use Urinary Catheter with water sachet. Female Nelaton 6" 18FR
• 07392532194122: Single Use Urinary Catheter with water sachet. Female Nelaton 6" 16FR
• 07392532194092: Single Use Urinary Catheter with water sachet. Female Nelaton 6" 14FR
• 07392532194078: Single Use Urinary Catheter with water sachet. Female Nelaton 6" 12FR
• 07392532194030: Single Use Urinary Catheter with water sachet. Female Nelaton 6" 10FR
• 07392532194009: Single Use Urinary Catheter with water sachet. Female Nelaton 6" 08FR