Scheker Prosthesis

GUDID B013DRUJLDG250

Locking Drill Guide 2.5mm

APTIS MEDICAL, LLC

Joint prosthesis implantation kit, reusable
Primary Device IDB013DRUJLDG250
NIH Device Record Keyffce8f5a-d9e3-409c-aeff-dc83f2c0dcec
Commercial Distribution Discontinuation2019-05-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameScheker Prosthesis
Version Model NumberDRUJ-LDG25
Company DUNS780455338
Company NameAPTIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com
Phone502-425-8584
Emailinfo@aptismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB013DRUJLDG250 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

[B013DRUJLDG250]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-09
Device Publish Date2019-05-14

Devices Manufactured by APTIS MEDICAL, LLC

B013DRUJKW450 - Scheker DRUJ2023-06-16 K-Wire D. TROCAR .045"
B013DRUJLDG250 - Scheker Prosthesis2023-06-09Locking Drill Guide 2.5mm
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.