Monster® Screw System P20-915-4000

GUDID 00889795035974

Countersink, 4.0 Headless

PARAGON 28, INC.

Surgical countersink, reusable

• Primary Device ID: 00889795035974
• NIH Device Record Key: 5f5bea14-50a3-403b-a275-a81eb7aedcdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monster® Screw System
• Version Model Number: P20-915-4000
• Catalog Number: P20-915-4000
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00889795035974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190586

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

[00889795035974]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [Monster® Screw System]

• 00889795100795: Mini Monster 4.0 X 80mm Headed Screw, Long Thread
• 00889795100788: Mini Monster 4.0 X 75mm Headed Screw, Long Thread
• 00889795100771: Mini Monster 4.0 X 70mm Headed Screw, Long Thread
• 00889795100764: Mini Monster 4.0 X 65mm Headed Screw, Long Thread
• 00889795100610: Mini Monster 4.0 X 26mm Headed Screw, Long Thread
• 00889795100603: Mini Monster 4.0 X 24mm Headed Screw, Long Thread
• 00889795100597: Mini Monster 4.0 X 22mm Headed Screw, Long Thread
• 00889795100580: Mini Monster 4.0 X 20mm Headed Screw, Long Thread
• 00889795097460: Precision® JMF™ Screw Washer Caddy Lid
• 00889795097453: Precision® JMF™ Screw Washer Caddy Base
• 00889795097446: Precision® JMF™ Screw Solid Caddy Base
• 00889795097439: 1.6mm S/S Tube - No Cap
• 00889795097422: Precision® JMF™ Screw Cannulated Caddy Base
• 00889795054722: ø0.9mm K-Wire Tube
• 00889795053497: Monster, Countersink, 7.0mm, Bowl Washer
• 00889795052346: P28, Drill, Ø3.2mm x 18cm, Cann
• 00889795052018: Drill, 2.8mm x 180mm, Cannulated, AO
• 00889795052001: Drill, 3.8mm x 180mm, Cannulated, AO
• 00889795049148: Ø1.2mm K-Wire Tube
• 00889795048950: P28, Drill, 3.5 x 200 mm, Cannulated, 3/16 Sq, SS
• 00889795048943: P28, Drill, 3.3 x 200 mm, Cannulated, 3/16 Sq, SS
• 00889795047724: Countersink, Ø7.2mm x 200mm, Headless, SS
• 00889795040756: Over Drill, 7.0 x 200mm, Cannulated, 3/16" Sq. Connection
• 00889795040749: Over Drill, 5.5 x 130mm, Cannulated, 3/16" Sq. Connection
• 00889795040732: Drill, 4.6 x 340mm, Long, Cannulated, 3/16 Sq., SS
• 00889795040725: Drill, 4.6 x 250mm, Standard, Cannulated, 3/16 Sq. Connection
• 00889795040718: Drill, 4.6 x 220mm, Cannulated, 3/16" Sq. Connection
• 00889795040701: Over Drill, 4.5 x 110mm, Cannulated, 3/16" Sq. Connection
• 00889795040695: Over Drill, 4.0 x 110mm, Cannulated, AO
• 00889795040671: Drill, 3.5 x 160mm, Cannulated, AO
• 00889795040664: Over Drill, 3.5 x 110mm, Cannulated, AO
• 00889795040640: Over Drill, 3.0 x 110mm, Cannulated, AO
• 00889795040633: Drill, 2.9 x 140mm, Cannulated, 3/16" Sq. Connection
• 00889795040541: Over Drill, 4.0/4.2 x 120mm, Solid, Trocar Tip, AO
• 00889795040527: Over Drill, 3.5 x 110mm, Solid, Trocar Tip, AO
• 00889795040497: Over Drill, 2.7 x 120mm, Solid, Trocar Tip, AO
• 00889795040473: Drill, 2.6 x 130mm, Solid, Trocar Tip, AO
• 00889795040442: Drill, 2.3 x 120mm, Solid, Trocar Tip, AO
• 00889795040404: Drill, 1.7 x 120mm, Solid, Trocar Tip, AO
• 00889795038555: Lapidus Nail, Reamer, 5.5mm, Cannulated
• 00889795038456: Tap, 5.5mm x 140mm, Beaming
• 00889795038449: Tap, 5.0mm x 140mm, Beaming
• 00889795036018: Countersink, 7.0 Headless
• 00889795036001: Countersink, 5.5 Headless
• 00889795035998: Countersink, 5.0mm Headless Beaming
• 00889795035981: Countersink, 4.5 Headless
• 00889795035974: Countersink, 4.0 Headless
• 00889795035967: Countersink, 3.5 Headless
• 00889795035950: Countersink, 3.0 Headless
• 00889795035943: Countersink, 2.5 Headless