ENVOY 55625800

GUDID 10886704027959

ENVOY Guiding Catheter MPD 100 cm 5F (1.65 mm) .056 Inch (1.4 mm)

Medos International Sàrl

Vascular guide-catheter, single-use

• Primary Device ID: 10886704027959
• NIH Device Record Key: 587a1569-b7c8-4470-a0db-0aebb3446c65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENVOY
• Version Model Number: 556-258-00
• Catalog Number: 55625800
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Storage Environment Temperature: Between 0 and 130 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704027959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093184

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-27
• Device Publish Date: 2016-06-30

On-Brand Devices [ENVOY]

• 10886704031802: ENVOY XB Guiding Catheter STR 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031796: ENVOY Guiding Catheter STR 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031789: ENVOY XB Guiding Catheter STR 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031772: ENVOY Guiding Catheter STR 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031765: ENVOY XB Guiding Catheter MPD 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031758: ENVOY Guiding Catheter MPD 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031741: ENVOY XB Guiding Catheter MPD 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031734: ENVOY Guiding Catheter MPD 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031727: ENVOY XB Guiding Catheter MPC 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031710: ENVOY Guiding Catheter MPC 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031703: ENVOY XB Guiding Catheter MPC 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031697: ENVOY Guiding Catheter MPC 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031680: ENVOY XB Guiding Catheter H 1 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031673: ENVOY Guiding Catheter H 1 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031666: ENVOY XB Guiding Catheter H 1 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031659: ENVOY Guiding Catheter H 1 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031642: ENVOY XB Guiding Catheter SIM 2 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031635: ENVOY Guiding Catheter SIM 2 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031628: ENVOY XB Guiding Catheter SIM 2 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031611: ENVOY Guiding Catheter SIM 2 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031604: ENVOY XB Guiding Catheter CBL MOD (BURKE) 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031598: ENVOY Guiding Catheter CBL MOD (BURKE) 90 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031581: ENVOY XB Guiding Catheter CBL MOD (BURKE) 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704031574: ENVOY Guiding Catheter CBL MOD (BURKE) 100 cm 6F (2.0 mm) .070 Inch (1.8 mm)
• 10886704027980: ENVOY Guiding Catheter STR 90 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027973: ENVOY Guiding Catheter STR 100 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027966: ENVOY Guiding Catheter MPD 90 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027959: ENVOY Guiding Catheter MPD 100 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027942: ENVOY Guiding Catheter MPC 90 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027935: ENVOY Guiding Catheter MPC 100 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027928: ENVOY Guiding Catheter H 1 90 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027911: ENVOY Guiding Catheter H 1 100 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027904: ENVOY Guiding Catheter CBL MOD (BURKE) 90 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704027898: ENVOY Guiding Catheter CBL MOD (BURKE) 100 cm 5F (1.65 mm) .056 Inch (1.4 mm)
• 10886704075042: ENVOY Guiding Catheter STR 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704075035: ENVOY Guiding Catheter SIM 2 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704075004: ENVOY Guiding Catheter MPD 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074984: ENVOY Guiding Catheter MPC 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074960: ENVOY Guiding Catheter H1 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074946: ENVOY Guiding Catheter CBL MOD (BURKE) 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074922: ENVOY Guiding Catheter STR 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074915: ENVOY Guiding Catheter SIM 2 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074885: ENVOY Guiding Catheter MPD 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074861: ENVOY Guiding Catheter MPC 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074847: ENVOY Guiding Catheter H1 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074823: ENVOY Guiding Catheter CBL MOD (BURKE) 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704075059: ENVOY XB Guiding Catheter STR 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704075028: ENVOY XB Guiding Catheter SIM 2 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704075011: ENVOY XB Guiding Catheter MPD 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)
• 10886704074991: ENVOY XB Guiding Catheter MPC 90 cm 7F (2.3 mm) .078 Inch (2.0 mm)