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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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Ortho FlexTech - D798SSOFTSAM0

Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFTSAM0 ()
SSOFT

  • Orthodontic retainer

Ortho FlexTech - D798SSOFT0

Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFT0 ()
SSOFT

  • Orthodontic retainer

Ortho FlexTech - D798SAMSSOFT0

Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
Not in Commercial Distribution

  • D798SAMSSOFT0 ()
SSOFT

  • Orthodontic retainer

Excel Fast - D7981EFSB0

Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part B in a 6gm syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1EFSB
In Commercial Distribution

  • D7981EFSB0 ()
1EFSB

  • Orthodontic bracket adhesive

BandLok - D798BLSA0

BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSA
In Commercial Distribution

  • D798BLSA0 ()
BLSA

  • Orthodontic bracket adhesive

Cadence™ - 10381780240174

Cadence Talar Sizer Holder is used to hold the Talar Sizer that is used to measure the proper size Talar Dome Trial.
Ascension Orthopedics, Inc.
10203008
In Commercial Distribution

  • M268102030081 ()
  • 10381780240174 ()

  • Large
10203008

  • Orthopaedic implant/instrument assembling device

Tinto Myelin Basic Protein, RPab - B502BSB57800

Tinto Myelin Basic Protein 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

  • B502BSB57800 ()
BSB 5780

  • Myelin basic protein IVD, antibody

ATRX (RBT-ATRX) - B502BSB371110

ATRX is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3711-1
In Commercial Distribution

  • B502BSB371110 ()

  • Total Volume: 1 Milliliter
BSB-3711-1

  • Alpha thalassemia/mental retardation syndrome X-linked (ATRX) IVD, antibody

ATRX (RBT-ATRX) - B502BSB3711050

ATRX is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3711-05
In Commercial Distribution

  • B502BSB3711050 ()

  • Total Volume: 0.5 Milliliter
BSB-3711-05

  • Alpha thalassemia/mental retardation syndrome X-linked (ATRX) IVD, antibody

ATRX (RBT-ATRX) - B502BSB3711010

ATRX is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3711-01
In Commercial Distribution

  • B502BSB3711010 ()

  • Total Volume: 0.1 Milliliter
BSB-3711-01

  • Alpha thalassemia/mental retardation syndrome X-linked (ATRX) IVD, antibody

ATM (EP327) - B502BSB371010

ATM is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3710-1
In Commercial Distribution

  • B502BSB371010 ()

  • Total Volume: 1 Milliliter
BSB-3710-1

  • Ataxia telangiectasia mutated (ATM) protein IVD, antibody

ATM (EP327) - B502BSB3710050

ATM is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3710-05
In Commercial Distribution

  • B502BSB3710050 ()

  • Total Volume: 0.5 Milliliter
BSB-3710-05

  • Ataxia telangiectasia mutated (ATM) protein IVD, antibody

ATM (EP327) - B502BSB3710010

ATM is rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3710-01
In Commercial Distribution

  • B502BSB3710010 ()

  • Total Volume: 0.1 Milliliter
BSB-3710-01

  • Ataxia telangiectasia mutated (ATM) protein IVD, antibody

Tinto Factor VIII-Related Antigen, RPab - B502BSB54980

Tinto Factor VIII-Related Antigen 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

  • B502BSB54980 ()
BSB 5498

  • Coagulation factor VIII-associated antigen IVD, antibody

CD99 MMab - B502BSB53140

CD99 is mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB53140 ()
BSB 5314

  • CD99 cell marker IVD, antibody

CD99 MMab - B502BSB53130

CD99 is mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB53130 ()
BSB 5313

  • CD99 cell marker IVD, antibody

CD99 MMab - B502BSB53120

CD99 is mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB53120 ()
BSB 5312

  • CD99 cell marker IVD, antibody

bcl6 MMab - B502BSB34380

bcl6 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in bufferpH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB34380 ()
BSB 3438

  • Bcl-6 protein IVD, antibody

MUC2 RMab - B502BSB69510

Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB69510 ()
BSB 6951

  • Mucin IVD, antibody

MUC2 RMab - B502BSB69500

Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB69500 ()
BSB 6950

  • Mucin IVD, antibody

MUC2 RMab - B502BSB69490

Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB69490 ()
BSB 6949

  • Mucin IVD, antibody

Tinto MUC2 RMab - B502BSB69480

Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB69480 ()
BSB 6948

  • Mucin IVD, antibody

Tinto MUC2 RMab - B502BSB69470

Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB69470 ()
BSB 6947

  • Mucin IVD, antibody

Tinto MUC2 RMab - B502BSB69460

Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB69460 ()
BSB 6946

  • Mucin IVD, antibody

Tinto BG8 LewisY - B502BSB63750

BG8 LewisY is an antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB63750 ()
BSB 6375

  • Lewis y antigen IVD, antibody

Tinto BG8 LewisY - B502BSB63740

BG8 LewisY is an antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB63740 ()
BSB 6374

  • Lewis y antigen IVD, antibody

Tinto BG8 LewisY - B502BSB63730

BG8 LewisY is an antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB63730 ()
BSB 6373

  • Lewis y antigen IVD, antibody

Integra® External Fixation System - 10381780125433

The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution

  • 10381780125433 ()

  • 1.28 in L
12225221

  • External orthopaedic fixation system, reusable

Integra® External Fixation System - 10381780125136

The extended compression distraction nut is manufactured from stainless steel and is used to secure components in the Integra External Fixation System.
Ascension Orthopedics, Inc.
12224216
In Commercial Distribution

  • 10381780125136 ()

  • .59 in H x .394 in top dia
12224216

  • External orthopaedic fixation system, reusable

Integra® Proximal Humeral Fracture Plate System - 10381780121077

The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3540CS
In Commercial Distribution

  • M269PSS3540CS1 ()
  • 10381780121077 ()

  • 1.675 in L x .138 in dia
PSS3540CS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
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