Rotation Medical Bone Staple

GUDID 00854501006111

ROTATION MEDICAL, INC.

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00854501006111
• NIH Device Record Key: 81b6cabc-bcd2-47ae-b155-50db6cd43005
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotation Medical Bone Staple
• Version Model Number: 2503-S
• Company DUNS: 031098401
• Company Name: ROTATION MEDICAL, INC.
• 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: false
• 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	00854501006111 [Primary]

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: 2017-05-18

Devices Manufactured by ROTATION MEDICAL, INC.

• 00885556735657 - Bioinductive Implant with Arthroscopic Delivery System - Medium: 2019-08-28
• 00885556735664 - Bioinductive Implant with Arthroscopic Delivery System - Large: 2019-08-28
• 00854501006043 - Rotation Medical Arthroscopic Implant Set With Staples: 2019-03-21
• 00854501006074 - Rotation Medical Bone Staple Drivers With Staples: 2019-03-21
• 00854501006111 - Rotation Medical Bone Staple: 2019-03-21
• 00854501006111 - Rotation Medical Bone Staple: 2019-03-21
• 00854501006159 - Bone Anchors with Arthroscopic Delivery System - Advanced: 2019-03-21
• 00854501006173 - Bone Anchors with Arthroscopic Delivery System: 2019-03-21
• 00854501006067 - Rotation Medical Tendon Staples: 2019-01-08