Paradigm PRSB

GUDID 10845854083017

Paradigm Revolution Small Boot, Pair

Conmed Corporation

Traction boot

• Primary Device ID: 10845854083017
• NIH Device Record Key: aec608d5-3b25-4552-b9e8-1eb2226caaed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradigm
• Version Model Number: PRSB
• Catalog Number: PRSB
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854083017 [Direct Marking]
GS1	30845854083011 [Primary]

FDA Product Code

• HST: Apparatus, traction, non-powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

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• 30845854648609: Paradigm Slim Raven Suture Passer, 15 deg Up
• 20845854901417: Paradigm Slim Raven Suture Passer, 15 deg Up
• 30845854082328: Paradigm™Curved Knot Pusher
• 20653405986826: Paradigm™ ClickLok™ Drill Guide, Curved Crown
• 20653405986819: Paradigm™ ClickLok™ Drill Guide, Straight Fish Mouth
• 20653405986802: Paradigm™ ClickLok™ Drill Guide, Straight Crown
• 20653405986796: Paradigm™ ClickLok™ Drill Guide Obturator
• 20653405986789: Paradigm™ ClickLok™ Drill Bit, 2.1mm
• 20653405986772: Paradigm™ ClickLok™ Anchor, Black #2 Suture
• 20653405986765: Paradigm™ ClickLok™ Anchor, Blue #2 Suture
• 20845854902575: Paradigm, Retractable Blade, Hook
• 20845854902568: Paradigm Retractable Blade, Straight
• 20845854649982: Paradigm, Retractable Blade, Hook
• 20845854649975: Paradigm Retractable Blade, Straight
• 10845854083048: Paradigm Revolution Medium Boot, Pair
• 10845854083024: Paradigm Revolution Large Boot, Pair
• 10845854083017: Paradigm Revolution Small Boot, Pair
• 10845854083000: Paradigm Revolution Hip Distractor, DN
• 10845854082997: Paradigm Revolution Hip Distractor, UK
• 10845854082980: Paradigm Revolution Hip Distractor, JP
• 10845854082973: Paradigm Revolution Hip Distractor, EU
• 10845854082966: Paradigm Revolution Hip Distractor, US
• 20845854082932: Paradigm Revolution Perineal Post Pad - Dual Density
• 20845854082925: Paradigm Revolution Perineal Post Pad
• 30845854082915: Paradigm Boot Disposable Liner, Medium Pair
• 30845854082908: Paradigm Boot Disposable Liner, Small Pair
• 30845854082533: Paradigm Boot Disposable Liner, Large Pair
• 10845854083031: Paradigm Revolution Right Leg Boom
• 10845854082959: Paradigm Revolution Left Leg Boom
• 20845854901585: PARADIGM ALL-SUTURE ANCHOR 1.8MM, WHITE/BLACK #2
• 20845854650292: PARADIGM ALL-SUTURE ANCHOR 1.8MM, WHITE/BLACK #2
• 20845854082482: Paradigm EZ Switch Portal Saver System, Universal, 8.5 mm x 150 mm
• 10845854082492: Paradigm Access Kit and EZ Switch Portal Saver, Universal