PROWLER MC1755F2U

GUDID 10886704085591

PROWLER XS microcatheter Contents: 1 microcatheter and 1 shaping mandrel 150 cm 5 cm 2 Markers 45° .0165" (0.4 mm) 1.9F (0.65 mm) 2.3F (0.75 mm)

Medos International Sàrl

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

• Primary Device ID: 10886704085591
• NIH Device Record Key: d7e60db2-c478-4db3-b93e-755d2e9c07ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROWLER
• Version Model Number: MC1755F2U
• Catalog Number: MC1755F2U
• 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	10886704085591 [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