Integra®

GUDID M433495361

Fleece Comfort Headbands

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

General-purpose light source

• Primary Device ID: M433495361
• NIH Device Record Key: 0ab8683c-c873-463b-a037-11c95377bc00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: 49536
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Device Count: 3
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780167870 [Unit of Use]
GS1	10381780167877 [Primary]
HIBCC	M433495361 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864380

FDA Product Code

• FST: LIGHT, SURGICAL, FIBEROPTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-09-09

On-Brand Devices [Integra®]

• 10381780086918: Ruler, Stainless Steel, Graduated in mm and Inches
• 10381780086475: Andrews-Pynchon Suction Tube, Stainless Steel
• 10381780086468: Andrews Suction Tube, Removable Tip
• 10381780086451: Yankauer Suction Tube, Stainless Steel, Small, Narrow Handle
• 10381780086444: Yankauer Suction Tube, Stainless Steel
• 10381780086239: Laryngeal Suction Tube, 3mm Outer Diameter
• 10381780086222: Laryngeal Suction Tube, 2.5mm Outer Diameter
• 10381780086215: Laryngeal Suction Tube, 2mm Outer Diameter
• 10381780084884: McGee Suction Tube, 26 Gauge, 2-3/4" Working Length
• 10381780084877: McGee Suction Tube, 24 Gauge, 2-3/4" Working Length
• 10381780084860: McGee Suction Tube, 22 Gauge, 2-3/4" Working Length
• 10381780084228: House Suction Irrigator, 12 Fr. x 14 Fr., 3-1/2"
• 10381780084211: House Suction Irrigator, 8 Fr. x 12 Fr., 3-1/2"
• 10381780084204: House Suction Irrigator, 7 Fr. x 10 Fr., 3-1/2"
• 10381780084198: House Suction Irrigator, 6 Fr. x 8 Fr., 3-1/2"
• 10381780084181: House Suction Irrigator, 5 Fr. x 7 Fr., 3-1/2"
• 10381780084174: House Suction Irrigator, 4 Fr. x 5 Fr., 3-1/2"
• 10381780084167: House Suction Irrigator, 4 Fr. x 5 Fr., 2-3/4"
• 10381780084150: House Suction Irrigator, 2.5 Fr. x 4 Fr., 3-1/2"
• 10381780084143: House Suction Irrigator, 2.5 Fr. x 4 Fr., 2-3/4"
• 10381780084136: House Suction Irrigator, 2 Fr. x 2.5 Fr., 3-1/2"
• 10381780084129: House Cutoff Suction Adapter
• 10381780084112: Guilford-Wright Suction Tube, 24 Gauge
• 10381780084105: Guilford-Wright Suction Tube, 22 Gauge
• 10381780084099: Guilford-Wright Suction Tube, 20 Gauge
• 10381780084082: Schuknecht Suction Tube, 24 Gauge
• 10381780084075: Schuknecht Suction Tube, 22 Gauge
• 10381780084068: Schuknecht Suction Tube, 20 Gauge
• 10381780084051: Rosen Suction Tube, 24 Gauge
• 10381780084044: Rosen Suction Tube, 22 Gauge
• 10381780084037: Rosen Suction Tube, 20 Gauge
• 10381780084020: Rosen Suction Tube, 18 Gauge
• 10381780084013: Rosen Suction Tube, 16 Gauge
• 10381780084006: Rosen Suction Tube, 15 Gauge
• 10381780083993: Rosen Suction Tube, 14 Gauge
• 10381780083986: Bellucci Suction Cannula Only, without Tips
• 10381780083979: Bellucci Suction Tube Tip Only, 24 Gauge
• 10381780083962: Bellucci Suction Tube Tip Only, 22 Gauge
• 10381780083955: Bellucci Suction Tube Tip Only, 20 Gauge
• 10381780083948: Bellucci Suction Tube Tip Only, 18 Gauge
• 10381780083931: Bellucci Suction Tube with 3 Tips (18, 20, 22 Gauges)
• 10381780083924: Barnes Suction Tube 9 Fr., 6-3/4"
• 10381780083917: Brackman Suction Tube, 7 Fr.
• 10381780083900: Brackman Suction Tube, 5 Fr.
• 10381780083894: Barnes Suction Tube, 6 Fr., 2mm Diameter
• 10381780083887: Barnes Suction Tube, 5 Fr., 1.7mm Diameter
• 10381780083870: Barnes Suction Tube, 4 Fr., 1.5mm Diameter
• 10381780083863: House-Baron Suction Tube, Extra Long, 7 Fr., 4-3/8"
• 10381780083856: House-Baron Suction Tube, Extra Long, 5 Fr., 4-3/8"
• 10381780083832: House-Baron Suction Tube, Extra Long, 7 Fr., 4"