Parcus Instrumentation

GUDID 00816342021265

10372 THREADED DILATOR

PARCUS MEDICAL LLC

Orthopaedic bone screw starter/notcher

• Primary Device ID: 00816342021265
• NIH Device Record Key: 4447e1c8-c4a7-4974-b9ee-dcbe071a854a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parcus Instrumentation
• Version Model Number: 10372
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00816342021265 [Primary]

FDA Product Code

• HWX: Tap, Bone

Sterilization

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

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

[00816342021265]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Parcus Instrumentation]

• 00816342025140: 4.5mm Twist Biocomposite Soft Bone Tap w/ Handle
• 00816342025096: Universal Sterilization Tray w/ Pin Mat
• 00816342025072: Suture Pull Handle
• 00816342024792: Threaded Dilator w/Sm. Hudson
• 00816342024785: 6.5mm Twist Biocomposite Tap w/ Handle
• 00816342024778: 5.5mm Twist Biocomposite Tap w Handle
• 00816342024761: 4.5mm Twist Biocomposite Tap w/ Handle
• 00816342024648: Synd-EZ Drill Guide
• 00816342024631: 4.8mm SLiK Awl
• 00816342024624: 3.6mm awl
• 00816342024594: 10321 FEMALE COMP ADJ ANGL AND OFFST
• 00816342024587: 10319 Drill Guide Cannula
• 00816342024525: Twist Knotless Tap, Final Assembly, Unsterile
• 00816342024426: Graft Size Block Short
• 00816342024310: 10838 FEMORAL NOTCHER
• 00816342024082: 4.0 x 100 mm Drill Guide, 6-Point
• 00816342024068: 3.6 to 4.1mm Tapered Awl
• 00816342023764: Drill Guide 8-point Slotted Hip Length Unsterile
• 00816342023757: 3.5mm 8 Point Drill Guide Final Assembly
• 00816342023702: Obturator Assembly, Cannulated, Conical Tip, Hip Length
• 00816342023696: Obturator Assembly, Cannulated, Conical Tip
• 00816342023689: Shoulder Set Tray
• 00816342023665: Threaded 4.5mm Tap
• 00816342023641: 8-Point Slotted Knotless Drill Guide, w/ Beaver Tail Handle
• 00816342023627: Conical Tip, Hip Length Obturator Assembly
• 00816342023610: Conical Tip Obturator
• 00816342023603: Drill Guide - 100mm - 8-Point
• 00816342023498: 4.1mm Awl
• 00816342023306: Graft Size Block
• 00816342023290: 35/90 Adjustable Guide
• 00816342023283: 10291 Tibial Drill Guide, Hook,Elbow
• 00816342022019: ACL Tray Case
• 00816342021579: 3.5mm Draw Tight Drill Guide Shaft and Handle Assembly
• 00816342021524: 10556 CHONDRAL PICK 45 DEGREE
• 00816342021517: 10555 CHONDRAL PICK 15 DEGREE
• 00816342021500: 10554 CHONDRAL PICK STRAIGHT
• 00816342021463: 10512 BONE TUNNEL PLUG CANNULATED
• 00816342021449: 10500 BONE TUNNEL PLUG NON CANN
• 00816342021388: 3.5mm 8 Point drill guide final assembly
• 00816342021326: 10411 4.75mm Slotted Tendon Harvestr
• 00816342021319: Blunt Tip Obturator
• 00816342021302: Trocar Tip Obturator
• 00816342021296: 2.8 mm Switching Stick
• 00816342021289: 10390 5.5mm Closed Tendon Harvester
• 00816342021272: 10389 4.75mm Closed Tendon Harvester
• 00816342021265: 10372 THREADED DILATOR
• 00816342021258: 3.2mm Awl with Handle
• 00816342021180: 3.5mm V Mouth Drill Guide Final Assembly
• 00816342021050: Punch Tap Use with 5.5-6.5mm PEEK PEEK CF
• 00816342020961: Punch/Tap, Str Anc, 5.5-6.5