Rotation Medical Arthroscopic Implant Set With Staples 2516-1

GUDID 00854501006043

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 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: 00854501006043
• NIH Device Record Key: 8ecec753-f1da-4a3d-a322-be0a5a80e63a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotation Medical Arthroscopic Implant Set With Staples
• Version Model Number: 2516
• Catalog Number: 2516-1
• Company DUNS: 031098401
• Company Name: ROTATION MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00854501006043 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2015-10-23

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
• 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
• 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