RoG Rope

GUDID 10855152006038

UHMWPE #2 Suture

Rog Sports Medicine, Inc.

Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 10855152006038
• NIH Device Record Key: 37c8dd3e-e570-498a-8408-9a5194d230c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RoG Rope
• Version Model Number: 10-1341
• 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: true
• 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	00855152006031 [Primary]
GS1	10855152006038 [Package]; Contains: 00855152006031; 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: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-13

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: 2019-02-07UHMWPE #2 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: 2018-07-06 2.9mm Suture Anchor with 2x 36" UHMWPE #2 suture