Parcus Instrumentation

GUDID 00816342023634

3.0mm x 100mm Reusable Drill Bit with Stop

PARCUS MEDICAL LLC

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable
Primary Device ID00816342023634
NIH Device Record Key29962229-f624-448c-966a-01134f19ad5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameParcus Instrumentation
Version Model Number10482U
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342023634 [Primary]

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


[00816342023634]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-29

On-Brand Devices [Parcus Instrumentation]

008163420251404.5mm Twist Biocomposite Soft Bone Tap w/ Handle
00816342025096Universal Sterilization Tray w/ Pin Mat
00816342025072Suture Pull Handle
00816342024792Threaded Dilator w/Sm. Hudson
008163420247856.5mm Twist Biocomposite Tap w/ Handle
008163420247785.5mm Twist Biocomposite Tap w Handle
008163420247614.5mm Twist Biocomposite Tap w/ Handle
00816342024648Synd-EZ Drill Guide
008163420246314.8mm SLiK Awl
008163420246243.6mm awl
0081634202459410321 FEMALE COMP ADJ ANGL AND OFFST
0081634202458710319 Drill Guide Cannula
00816342024525Twist Knotless Tap, Final Assembly, Unsterile
00816342024426Graft Size Block Short
0081634202431010838 FEMORAL NOTCHER
008163420240824.0 x 100 mm Drill Guide, 6-Point
008163420240683.6 to 4.1mm Tapered Awl
00816342023764Drill Guide 8-point Slotted Hip Length Unsterile
008163420237573.5mm 8 Point Drill Guide Final Assembly
00816342023702Obturator Assembly, Cannulated, Conical Tip, Hip Length
00816342023696Obturator Assembly, Cannulated, Conical Tip
00816342023689Shoulder Set Tray
00816342023665Threaded 4.5mm Tap
008163420236418-Point Slotted Knotless Drill Guide, w/ Beaver Tail Handle
00816342023627Conical Tip, Hip Length Obturator Assembly
00816342023610Conical Tip Obturator
00816342023603Drill Guide - 100mm - 8-Point
008163420234984.1mm Awl
00816342023306Graft Size Block
0081634202329035/90 Adjustable Guide
0081634202328310291 Tibial Drill Guide, Hook,Elbow
00816342022019ACL Tray Case
008163420215793.5mm Draw Tight Drill Guide Shaft and Handle Assembly
0081634202152410556 CHONDRAL PICK 45 DEGREE
0081634202151710555 CHONDRAL PICK 15 DEGREE
0081634202150010554 CHONDRAL PICK STRAIGHT
0081634202146310512 BONE TUNNEL PLUG CANNULATED
0081634202144910500 BONE TUNNEL PLUG NON CANN
008163420213883.5mm 8 Point drill guide final assembly
0081634202132610411 4.75mm Slotted Tendon Harvestr
00816342021319Blunt Tip Obturator
00816342021302Trocar Tip Obturator
008163420212962.8 mm Switching Stick
0081634202128910390 5.5mm Closed Tendon Harvester
0081634202127210389 4.75mm Closed Tendon Harvester
0081634202126510372 THREADED DILATOR
008163420212583.2mm Awl with Handle
008163420211803.5mm V Mouth Drill Guide Final Assembly
00816342021050Punch Tap Use with 5.5-6.5mm PEEK PEEK CF
00816342020961Punch/Tap, Str Anc, 5.5-6.5

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