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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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mytaMed - B351201020

Adson Tissue Forceps, Serrated Standard-Tip
Mytamed, Inc.
2.01.02
Not in Commercial Distribution

  • B351201020 ()
2.01.02

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

mytaMed - B351200020

Bishop-Harmon Forceps, Standard, 1x2 Teeth
Mytamed, Inc.
2.00.02
Not in Commercial Distribution

  • B351200020 ()
2.00.02

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

mytaMed - B351200010

Bishop-Harmon Forceps, Standard, Serrated
Mytamed, Inc.
2.00.01
Not in Commercial Distribution

  • B351200010 ()
2.00.01

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Surgical Direct - B382SD1472420000

6 /2" Bone Impactor, 20mm, Aluminum Handle
Surgical Direct, Inc.
SD14724-2000
In Commercial Distribution

  • B382SD1472420000 ()
SD14724-2000

  • Orthopaedic bone-fragment manipulator, reusable

Accula Flu A / B Control Kit - B540FAB1100CWC0

The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Accula Programming Cassette - B540D20010

The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Accula Dock - B540D20000

The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Silaris Dock - B54010260

The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Silaris Influenza A&B Control Kit - B54010240

The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

HEMOSTAT JACKSON, SLIGHT CURVED, DLC, 19 CM - D928140052DLC0

No Description
W.H. Holden, Inc.
14-0052DLC
In Commercial Distribution

  • D928140052DLC0 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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