Tenodesis Screw System P41-930-7500

GUDID 00889795057488

Tissue Protector Insert 7.5, Grappler

PARAGON 28, INC.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00889795057488
• NIH Device Record Key: 59c4bcfd-2d21-4478-b924-279202da9a0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenodesis Screw System
• Version Model Number: P41-930-7500
• Catalog Number: P41-930-7500
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00889795057488 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

[00889795057488]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [Tenodesis Screw System]

• 00889795057587: Grappler Interference Screw, Caddy Lid
• 00889795057570: Grappler Interference Screw Instruments, Caddy
• 00889795057556: Grappler Interference Depth Gauge, 25mm
• 00889795057549: Screw Driver Attachment 7.0/8.0mm, Solid , A/O, Trilobe, Grappler
• 00889795057532: Screw Driver Attachment 5.5/6.0mm, Solid , A/O, Trilobe, Grappler
• 00889795057525: Screw Driver Attachment 4.5/5.0mm, Solid , A/O, Trilobe, Grappler
• 00889795057518: Screw Driver Attachment 4.0mm, Solid, A/O, Trilobe, Grappler
• 00889795057501: Tissue Protector Insert 8.5, Grappler
• 00889795057495: Tissue Protector Insert 8.0, Grappler
• 00889795057488: Tissue Protector Insert 7.5, Grappler
• 00889795057471: Tissue Protector Insert 7.0, Grappler
• 00889795057464: Tissue Protector Insert 6.5, Grappler
• 00889795057457: Tissue Protector Insert 6.0, Grappler
• 00889795057440: Tissue Protector Insert 5.5, Grappler
• 00889795057433: Tissue Protector Insert 5.0, Grappler
• 00889795057426: Tissue Protector Insert 4.5, Grappler
• 00889795057419: Tissue Protector Insert 4.0, Grappler
• 00889795057402: Tissue Protector Handle, Grappler
• 00889795057396: Tendon Sizer, Grappler
• 00889795053879: Grappler PEEK Interference Screw 8 x 25mm
• 00889795053862: Grappler PEEK Interference Screw 8 x 20mm
• 00889795053855: Grappler PEEK Interference Screw 7 x 25mm
• 00889795053848: Grappler PEEK Interference Screw 7 x 20mm
• 00889795053831: Grappler PEEK Interference Screw 6 x 25mm
• 00889795053824: Grappler PEEK Interference Screw 6 x 20mm
• 00889795053817: Grappler PEEK Interference Screw 6 x 15mm
• 00889795053800: Grappler PEEK Interference Screw 5.5 x 25mm
• 00889795053794: Grappler PEEK Interference Screw 5.5 x 20mm
• 00889795053787: Grappler PEEK Interference Screw 5.5 x 15mm
• 00889795053770: Grappler PEEK Interference Screw 5 x 25mm
• 00889795053763: Grappler PEEK Interference Screw 5 x 20mm
• 00889795053756: Grappler PEEK Interference Screw 5 x 15mm
• 00889795053749: Grappler PEEK Interference Screw 5 x 10mm
• 00889795053732: Grappler PEEK Interference Screw 4.5 x 20mm
• 00889795053725: Grappler PEEK Interference Screw 4.5 x 15mm
• 00889795053718: Grappler PEEK Interference Screw 4.5 x 10 mm
• 00889795053701: Grappler PEEK Interference Screw 4 x 20mm
• 00889795053695: Grappler PEEK Interference Screw 4 x 15mm
• 00889795053688: Grappler PEEK Interference Screw 4 x 10mm