Grappler Interference Screw System P99-197-1620

GUDID 00889795135346

Ø1.60mm x 20cm Eyelet Kirschner Wire, 316 LVM

PARAGON 28, INC.

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 00889795135346
• NIH Device Record Key: 1fdbc623-0b84-4fb2-b21c-5ffefd21e040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grappler Interference Screw System
• Version Model Number: P99-197-1620
• Catalog Number: P99-197-1620
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795135346 [Primary]

FDA Product Code

• HXI: PASSER, WIRE, ORTHOPEDIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [Grappler Interference Screw System]

• 00889795057563: Suture Passer w/ Braided Nitinol Loop, Grappler™
• 00889795057389: Drill, 8.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057372: Drill, 8.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057365: Drill, 7.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057358: Drill, 7.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057341: Drill, 6.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057334: Drill, 6.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057327: Drill, 5.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057310: Drill, 5.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057303: Drill, 4.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795057297: Drill, 4.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
• 00889795107589: PALM Ratcheting Driver Handle w/ AO Connect w/ Suture Cleat
• 00889795107572: Blind Tunnel Driver Handle w/ AO Connect w/ Suture Cleat
• 00889795107565: Blind-Tunnel Suture Loop Guide Rod w/ Nitinol Loop
• 00889795107558: Ø7.0/8.0 Driver Sleeve
• 00889795107541: Ø5.5/6.0 Driver Sleeve
• 00889795107534: Ø4.5/5.0 Driver Sleeve
• 00889795107527: Ø7.0/8.0 Driver, Cannulated
• 00889795107510: Ø5.5/6.0 Driver, Cannulated
• 00889795107503: Ø8.5 Cannulated Drill w/ Depth Markings
• 00889795107497: Ø8.0 Cannulated drill w/ Depth Markings
• 00889795107206: Ø7.5 Cannulated Drill w/ Depth Markings
• 00889795107190: Ø7.0 Cannulated Drill w/ Depth Markings
• 00889795107183: Ø6.5 Cannulated Drill w/ Depth Markings
• 00889795107176: Ø6.0 Cannulated Drill w/ Depth Markings
• 00889795107169: Ø5.5 Cannulated Drill w/ Depth Markings
• 00889795107152: Ø5.0 Cannulated Drill w/ Depth Markings
• 00889795107145: Ø4.5 Cannulated Drill w/ Depth Markings
• 00889795107138: Ø4.0 Cannulated Drill w/ Depth Markings
• 00889795106315: Ø4.5/5.0 Driver, Cannulated
• 00889795135346: Ø1.60mm x 20cm Eyelet Kirschner Wire, 316 LVM