DRUJ-LSC20

GUDID B013DRUJLSC200

20 mm 3.5 Locking Screw

APTIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB013DRUJLSC200
NIH Device Record Key87d95616-f1ec-47f1-ae8f-e94837309cfb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDRUJ-LSC20
Catalog NumberDRUJ-LSC20
Company DUNS780455338
Company NameAPTIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB013DRUJLSC200 [Primary]

FDA Product Code

KXEProsthesis, Wrist, Hemi-, Ulnar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


[B013DRUJLSC200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-27

Devices Manufactured by APTIS MEDICAL, LLC

B013DRUJKW450 - Scheker DRUJ2023-06-16 K-Wire D. TROCAR .045"
B013DRUJLDG250 - Scheker Prosthesis2023-06-09 Locking Drill Guide 2.5mm
B013DRUJKW540 - Scheker DRUJ2021-12-06 K-Wire D. TROCAR 4" 1.4 MM [.054'"]
B013DRUJKWD0 - Scheker DRUJ2021-12-06 K-Wire Dispenser 6 3/4"
B013MITDRUJ1000 - Scheker DRUJ2021-12-06 Metal Instrument Tray, Distal Radioulnar Joint
B013MITINT1000 - Scheker DRUJ2021-12-06 Metal Instrument Tray, Interchangeable
B013DRUJB10200 - NA2021-09-06 Distal Radioulnar Joint Ball Size 10 or Size 20
B013DRUJB200 - NA2021-09-06 UHMWP Ball, 9.5 mm, Size 20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.