| Primary Device ID | B013DRUJD1000 |
| NIH Device Record Key | 740d88d0-3ebb-42ca-8f44-dc7210eeed60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scheker DRUJ |
| Version Model Number | DRUJ-D100 |
| Catalog Number | DRUJ-D100 |
| Company DUNS | 780455338 |
| Company Name | APTIS 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B013DRUJD1000 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B013DRUJD1000]
Moist Heat or Steam Sterilization
[B013DRUJD1000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| B013DRUJTRPT300 | Threaded Radial Plate Trial Sz 30 - 17mm |
| B013DRUJTRPT200 | Threaded Radial Plate Trial Sz 20 - 15mm |
| B013DRUJTRPT100 | Threaded Radial Plate Trial Sz 10 - 13mm |
| B013DRUJTDG250 | 2.5mm Threaded Drill Guide |
| B013DRUJT350 | 3.5mm Quick Connect Tap |
| B013DRUJSD1500 | 1.5mm Square Head Bit |
| B013DRUJSB1000 | Instrument Tray, Screw Block |
| B013DRUJQCEXT1000 | Quick Connect Extension |
| B013DRUJPB1000 | Radial Peg Drill Bit |
| B013DRUJMD1000 | Ulna Resection Measuring Device |
| B013DRUJMB300 | Blue Measuring Device Ball |
| B013DRUJMB10200 | Black Measuring Device Ball |
| B013DRUJK100P0 | Guide Wire/ Ulna Prep Pointed |
| B013DRUJK100B0 | Guide Wire/Ulna Prep Blunt |
| B013DRUJIT1000 | Instrument Tray |
| B013DRUJI100 | Plastic Impactor |
| B013DRUJHD350 | 2.5mm Hex Head Bit |
| B013DRUJH1000 | Quick Connect Handle |
| B013DRUJG1000 | Depth Gauge |
| B013DRUJFR0600 | Finish Reamer 6.0mm |
| B013DRUJFR0500 | Finish Reamer 5.0mm |
| B013DRUJFR0450 | Finish Reamer 4.5mm |
| B013DRUJFR0400 | Finish Reamer 4.0mm |
| B013DRUJD1000 | 2.5mm Drill Guide |
| B013DRUJCB0600 | Cannulated Drill Bit 6.0mm |
| B013DRUJCB0500 | Cannulated Drill Bit 5.0mm |
| B013DRUJCB0450 | Cannulated Drill Bit 4.5mm |
| B013DRUJCB0400 | Cannulated Drill Bit 4.0mm |
| B013DRUJB250 | 2.5mm Quick Connect Drill Bit |
| B013DRUJAW150 | 1.5mm Hex Head Allen Wrench |
| B013MITINT1000 | Metal Instrument Tray, Interchangeable |
| B013MITDRUJ1000 | Metal Instrument Tray, Distal Radioulnar Joint |
| B013DRUJKWD0 | K-Wire Dispenser 6 3/4" |
| B013DRUJKW540 | K-Wire D. TROCAR 4" 1.4 MM [.054'"] |
| B013DRUJKW450 | K-Wire D. TROCAR .045" |