ICONN Answer 5.5MM Suture Anchor 155000

GUDID 00860419000219

ICONN Answer 5.5MM Suture Anchor

ICONN ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00860419000219
• NIH Device Record Key: fe449254-6c96-40c9-85c1-39fccc4d33b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICONN Answer 5.5MM Suture Anchor
• Version Model Number: 155000
• Catalog Number: 155000
• Company DUNS: 055774745
• Company Name: ICONN ORTHOPEDICS LLC
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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 Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860419000219 [Primary]
GS1	10860419000216 [Package]; Package: Box [12 Units]; In Commercial Distribution
GS1	20860419000213 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-09-23

Devices Manufactured by ICONN ORTHOPEDICS LLC

• 00860419000202 - ICONN Answer 4.75MM Suture Anchor: 2019-03-21 ICONN Answer 4.75MM Suture Anchor
• 00860419000219 - ICONN Answer 5.5MM Suture Anchor: 2019-03-21ICONN Answer 5.5MM Suture Anchor
• 00860419000219 - ICONN Answer 5.5MM Suture Anchor: 2019-03-21 ICONN Answer 5.5MM Suture Anchor