PROWLER MC1755S2U

GUDID 10886704085584

PROWLER XS microcatheter Contents: 1 microcatheter and 1 shaping mandrel 150 cm 5 cm 2 Markers STRAIGHT .0165" (0.4 mm) 1.9F (0.65 mm) 2.3F (0.75 mm)

Medos International Sàrl

Vascular microcatheter

• Primary Device ID: 10886704085584
• NIH Device Record Key: 6bc41d50-f816-4de3-b070-dd79fd2445b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROWLER
• Version Model Number: MC1755S2U
• Catalog Number: MC1755S2U
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: true
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704085584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214025

FDA Product Code

• DQY: Catheter, percutaneous

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: 2022-06-01
• Device Publish Date: 2022-05-24

On-Brand Devices [PROWLER]

• 00878528009078: PROWLER microcatheter PROWLER 27 Microcatheter .0270 Inch I.D. - 150cm - Straight 90 cm 3 cm 3.0
• 10886704028765: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20c m 110 cm Cont
• 10886704028758: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .0
• 10886704028741: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .0
• 10886704028734: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 45 cm 150 cm Cont
• 10886704028727: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .0
• 10886704028710: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .0
• 10886704028703: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .0
• 10886704028697: PROWLER PLUS Infusion Catheter with 2 Markers Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .0
• 10886704028680: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 150 cm Cont
• 10886704028673: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 135 cm MAX
• 10886704028666: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 135 cm J Co
• 10886704028659: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 135 cm MP C
• 10886704028642: PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 135 cm Cont
• 10886704028635: PROWLER 14 Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .0165 Inch (0.4 mm) 50 cm 170 cm Cont
• 10886704028628: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .016
• 10886704028611: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .016
• 10886704028604: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .016
• 10886704028598: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .016
• 10886704028581: PROWLER 14 Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .0165 Inch (0.4 mm) 50 cm 150 cm Cont
• 10886704028574: PROWLER 14 Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .0165 Inch (0.4 mm) 50 cm 135 cm Cont
• 10886704028550: PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015
• 10886704028543: PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015
• 10886704028536: PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015
• 10886704028529: PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015
• 10886704028512: PROWLER 10 Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015 Inch (0.4 mm) 50 cm 150 cm Conte
• 10886704084709: PROWLER EX Microcatheter Tip Markers: 2 2.3F (0.75 mm) (0.95 mm) .021 Inch (0.5 mm) 15cm 170cm 3
• 10886704084693: PROWLER EX Microcatheter Tip Markers: 2 2.3F (0.75 mm) (0.95 mm) .021 Inch (0.5 mm) 5cm 160cm 3
• 10886704084662: PROWLER EX Microcatheter Tip Markers: 2 2.3F (0.75 mm) (0.95 mm) .021 Inch (0.5 mm) 5cm 150cm 3
• 10886704085614: PROWLER XS microcatheter Contents: 1 microcatheter and 1 shaping mandrel 150 cm 5 cm 2 Markers
• 10886704085607: PROWLER XS microcatheter Contents: 1 microcatheter and 1 shaping mandrel 150 cm 5 cm 2 Markers
• 10886704085591: PROWLER XS microcatheter Contents: 1 microcatheter and 1 shaping mandrel 150 cm 5 cm 2 Markers
• 10886704085584: PROWLER XS microcatheter Contents: 1 microcatheter and 1 shaping mandrel 150 cm 5 cm 2 Markers S