FlexBand Plus 41068

GUDID 00850003396187

FlexBand Plus 0.5 x 24 Strip with Suture

Artelon

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00850003396187
• NIH Device Record Key: 524fcce8-58ff-4c5f-b13b-c655d2ae28cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexBand Plus
• Version Model Number: 41068
• Catalog Number: 41068
• Company DUNS: 066284070
• Company Name: Artelon
• 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: false
• Serial Number: true
• 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: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com
• Phone: (800) 610-3446
• Email: tififni.wittwer@artelon.com

Device Dimensions

• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter
• Length: 24 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003396187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192112

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

[00850003396187]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [FlexBand Plus]

• 00850003396101: FlexBand Plus 0.3 x 32 Strip with Suture
• 00850003396095: FlexBand Plus 0.3 x 8 Strip with Suture
• 00850003396088: FlexBand Plus 0.3 x 16 Strip with Suture
• 00850003396071: FlexBand Plus 0.5 x 8 Strip with Suture
• 00850003396064: FlexBand Plus 0.5 x 16 Strip with Suture
• 00850003396057: FLexBand Plus 0.7 x 8 Strip with Suture
• 00850003396040: FlexBand Plus 0.7 x 16 Strip with Suture
• 00850003396033: FlexBand Plus 0.5 x 32 Strip with Suture
• 00850003396026: FLexBand Plus 0.7 x 32 Strip with Suture
• 00850003396187: FlexBand Plus 0.5 x 24 Strip with Suture