Dila-Cath Nelaton 40cm CH16 4061600

GUDID 07392532129490

Urinary catheter for intermittent dilatation

Dentsply Ih AB

Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated Urethral dilatation catheter, non-medicated

• Primary Device ID: 07392532129490
• NIH Device Record Key: b186522b-e857-4987-85cc-47a8b55a0d7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dila-Cath Nelaton 40cm CH16
• Version Model Number: 40616
• Catalog Number: 4061600
• Company DUNS: 354059073
• Company Name: Dentsply Ih AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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

• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 French
• Length: 40 Centimeter
• Catheter Gauge: 16 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.
• 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.
• 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	07392532088117 [Package]; Contains: 07392532131707; Package: Customer Packaging [30 Units]; In Commercial Distribution
GS1	07392532129490 [Package]; Contains: 07392532088117; Package: Transport Packaging [2 Units]; In Commercial Distribution
GS1	07392532131707 [Primary]

FDA Product Code

• FBX: SOUND, URETHRAL, METAL OR PLASTIC

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: 2019-12-23
• Device Publish Date: 2019-12-13

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• 07392532274305 - LoFric® Elle™: 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH10 / Nelaton 4" 10FR
• 07392532274336 - LoFric® Elle™: 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH12 / Nelaton 4" 12FR
• 07392532274367 - LoFric® Elle™: 2022-04-11 Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR
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