RoG Single 10-1201

GUDID 10855152006021

2.9mm Suture Anchor with 2x 36" UHMWPE #2 suture

Rog Sports Medicine, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10855152006021
• NIH Device Record Key: 39291ded-a76b-4fee-9ce4-73c76f8a08f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RoG Single
• Version Model Number: 10-1201
• Catalog Number: 10-1201
• Company DUNS: 006254430
• Company Name: Rog Sports Medicine, 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

Customer Support Contacts

• Phone: 708-494-9300
• Email: lexi@buyrog.com
• Phone: 708-494-9300
• Email: lexi@buyrog.com

Device Dimensions

• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855152006024 [Primary]
GS1	10855152006021 [Package]; Contains: 00855152006024; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113299

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

Devices Manufactured by Rog Sports Medicine, Inc.

• 00855152006048 - ROG Cuff Anchor: 2021-03-23 ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture
• 10855152006038 - RoG Rope: 2019-02-07 UHMWPE #2 Suture
• 00855152006000 - RoG Cuff Anchor 5.5mm: 2018-07-06 5.5mm suture anchor with 2x 36" UHMWPE #2 suture
• 10855152006014 - RoG 5.5mm Knotless Suture Anchor: 2018-07-06 RoG 5.5mm Knotless Suture Anchor
• 10855152006021 - RoG Single: 2018-07-062.9mm Suture Anchor with 2x 36" UHMWPE #2 suture
• 10855152006021 - RoG Single: 2018-07-06 2.9mm Suture Anchor with 2x 36" UHMWPE #2 suture