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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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OPERA SWING - 08054890480000

The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.
GENERAL MEDICAL MERATE SPA
X-RAY R&F REMOTE SYSTEM OPERA SWING
In Commercial Distribution

  • 08054890480000 ()

  • Weight: 1120 Kilogram


  • Stationary general-purpose fluoroscopic x-ray system, digital

BandLok - D798BLSB0

BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part B.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSB
In Commercial Distribution

  • D798BLSB0 ()
BLSB

  • Orthodontic bracket adhesive

EchoMark LP - B53620001

EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
2000
In Commercial Distribution

  • B53620001 ()

  • Small


  • Radiological image marker, implantable

Tinto Myoglobin, RPab - B502BSB58010

Tinto Myoglobin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB58010 ()
BSB 5801

  • Myoglobin IVD, antibody

Tinto Myoglobin, RPab - B502BSB58000

Tinto Myoglobin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB58000 ()
BSB 5800

  • Myoglobin IVD, antibody

Tinto Myoglobin, RPab - B502BSB57990

Tinto Myoglobin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB57990 ()
BSB 5799

  • Myoglobin IVD, antibody

Tinto Lysozyme, RPab - B502BSB57300

Tinto Lysozyme is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB57300 ()
BSB 5730

  • Lysozyme (muramidase) IVD, antibody

Uroplakin III RPab - B502BSB22910

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB22910 ()
BSB 2291

  • Uroplakin IVD, antibody

Uroplakin III RPab - B502BSB22900

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB22900 ()
BSB 2290

  • Uroplakin IVD, antibody

Uroplakin III RPab - B502BSB22890

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB22890 ()
BSB 2289

  • Uroplakin IVD, antibody
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