Grappler™ Suture Anchor System P44-121-5515-SK

GUDID 00889795114273

Grappler Suture Anchor, PEEK, ø5.5 x 15mm w/ Tape, Sterile Kit

PARAGON 28, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889795114273
• NIH Device Record Key: ed68884a-6a4c-4e48-8e0a-30d98d144658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grappler™ Suture Anchor System
• Version Model Number: P44-121-5515-SK
• Catalog Number: P44-121-5515-SK
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00889795114273 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-17
• Device Publish Date: 2022-08-09

On-Brand Devices [Grappler™ Suture Anchor System]

• 00889795123954: Suture Passer in pouch assembly
• 00889795121417: K-Wire with depth markings, 3.2mm 15cm
• 00889795114372: Cannulated Drill, ø4.5mm x 10cm, Sterile
• 00889795114365: Cannulated Drill, ø3.5mm x 10cm, Sterile
• 00889795114334: BridgeLine Suture Tape, 4mm, UHMWPE/PGLA, Sterile
• 00889795114327: BridgeLine Suture Tape, 4mm, UHMWPE, Sterile
• 00889795113313: Solid Drill, ø4.3mm x 10cm
• 00889795113306: Solid Drill, ø3.5mm x 10cm
• 00889795123930: Grappler Knotless, 2 Anchor, ø4.5 x 15mm, Sterile Kit with instruments
• 00889795123923: Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Anchor/Driver only, Sterile Kit
• 00889795123916: Grappler Knotless Anchor, PEEK, ø4.5 x 15mm, Anchor/Driver only, Sterile Kit
• 00889795119025: 5.5mm cannulated tap, chronic anchor
• 00889795119018: 4.5mm cannulated tap, chronic anchor
• 00889795114358: Cannulated Tap, Ø5.5mm x 10cm, Sterile
• 00889795114341: Cannulated Tap, Ø4.5mm x 10cm, Sterile
• 00889795114310: Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Sterile Kit
• 00889795114303: Grappler Knotless Anchor, PEEK, ø4.5 x 15mm, Sterile Kit
• 00889795114297: Grappler Suture Anchor, All-Suture, ø2.8mm, Sterile Kit
• 00889795114280: Grappler Suture Anchor, All-Suture, ø1.4mm, Sterile Kit
• 00889795114273: Grappler Suture Anchor, PEEK, ø5.5 x 15mm w/ Tape, Sterile Kit
• 00889795114266: Grappler Suture Anchor, PEEK, ø5.5 x 15mm, Sterile Kit
• 00889795114259: Grappler Suture Anchor, PEEK, ø4.5 x 15mm w/ Tape, Sterile Kit
• 00889795114242: Grappler Suture Anchor, PEEK, ø4.5 x 15mm, Sterile Kit
• 00889795114235: Grappler Suture Anchor, Titanium, ø4.5 x 15mm, Sterile Kit
• 00889795114228: Grappler Suture Anchor, Titanium, ø3.0 x 10mm, Sterile Kit
• 00889795132277: Grappler Suture Anchor, Titanium, ø3.0 x 12mm, Sterile Kit
• 70889795123946: Grappler Suture Anchor, Suture Passer, Sterile Kit pack of 10