Primary Device ID | B013DRUJTRPT300 |
NIH Device Record Key | fd5c5f6a-9552-473d-ad55-bb725e48d668 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Scheker DRUJ |
Version Model Number | DRUJ-TRPT30 |
Catalog Number | DRUJ-TRPT30 |
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 | B013DRUJTRPT300 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
Moist Heat or Steam Sterilization
[B013DRUJTRPT300]
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" |