Ax®

GUDID M711BTA1440

Al, SST, Silicone

Innovasis, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device IDM711BTA1440
NIH Device Record Key5d87e1a2-9884-4984-8516-fb139c8ffd8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAx®
Version Model NumberBTA-144
Company DUNS156567492
Company NameInnovasis, Inc.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711BTA1440 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

[M711BTA1440]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-03-31

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M711LS3120Al, Silicone, SST
M711LS3090SST
M711LS3880Al, Silicone, SST
M711BTA1250Polypropylene, Radel, SST
M711BTA1200Al, Nylon, Silicone
M711BTA1210Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
M711BTA1240Al, Nylon, Silicone
M711BTA1230Al, Nylon, Silicone
M711BTA1460Al, SST, Silicone
M711BTA1440Al, SST, Silicone
M711BTA1430Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
M711LS3360Anterior Cup Curette, Straight, Size 4, Al, Silicone, SST
M711LS3350Anterior Cup Curette, Straight, Size 2, Al, Silicone, SST
M711LS3340Anterior Cup Curette, Angled Up, Size 4, Al, Silicone, SST
M711LS3330Anterior Cup Curette, Angled Up, Size 2, Al, Silicone, SST
M711LS3320Anterior Triangle Curette, Double Sided, 11mm, Al, Silicone, SST
M711LS3310Anterior, Angled, Ring Curette, Double Sided, 9mm, Al, Silicone, SST
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