Re-Cord™ Knitted Retraction Cord #2 649105

GUDID 07540172009959

Gingival retraction cord, non-medicated

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Gingival retraction cord, medicated

• Primary Device ID: 07540172009959
• NIH Device Record Key: 5059b819-04e2-4ec1-ac08-d89a2648db80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Re-Cord™ Knitted Retraction Cord #2
• Version Model Number: 649105
• Catalog Number: 649105
• Company DUNS: 626406016
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0
• Length: 244 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sparks and flame.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540172009959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921601

FDA Product Code

• JES: FLOSS, DENTAL
• MVL: CORD, RETRACTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-04
• Device Publish Date: 2018-09-20