Rotation Medical Tendon Staples 2504-1

GUDID 00854501006067

ROTATION MEDICAL, INC.

Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 00854501006067
• NIH Device Record Key: 385c3d9b-3e54-4a29-ab34-feae5135933e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotation Medical Tendon Staples
• Version Model Number: 2504
• Catalog Number: 2504-1
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854501006067 [Primary]

FDA Product Code

• GDW: Staple, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-08
• Device Publish Date: 2015-10-23

Devices Manufactured by ROTATION MEDICAL, INC.

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• 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
• 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
• 00854501006067 - Rotation Medical Tendon Staples: 2019-01-08