Primary Device ID | 00816342021111 |
NIH Device Record Key | edaa0977-e7a2-4482-ab11-2e4333b1f264 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Parcus Instrumentation |
Version Model Number | 10307 |
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 | true |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00816342021111 [Primary] |
NBH | Accessories, Arthroscopic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
[00816342021111]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-03 |
Device Publish Date | 2023-07-26 |
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 |