| Primary Device ID | 00816342025140 |
| NIH Device Record Key | 5dfc58c2-71b0-49c0-9f96-762a890b8edd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Parcus Instrumentation |
| Version Model Number | 11433 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00816342025140 [Primary] |
| HWX | Tap, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
[00816342025140]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-14 |
| Device Publish Date | 2022-12-06 |
| 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 |