Grappler™ Suture Anchor System

Basic Information

• Brand Name: Grappler™ Suture Anchor System
• Primary DI: 00889795114334
• Version / Model: P44-310-0004-S
• Catalog Number: P44-310-0004-S
• Company Name: PARAGON 28, INC.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-05
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: 6c1d1b30-762d-4ca1-8572-aa52504f955c

Device Description

BridgeLine Suture Tape, 4mm, UHMWPE/PGLA, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBI	Fastener, fixation, nondegradable, soft tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795114334	GS1