FlexBand Plus

GUDID 00850003396057

FLexBand Plus 0.7 x 8 Strip with Suture

Artelon

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 00850003396057
• NIH Device Record Key: d83e008f-f131-4031-bf98-fecef0191aa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexBand Plus
• Version Model Number: 41055
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003396057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192112

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

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