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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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 B&B Monopolar Dissector - B089B653000

B&B E-P ELECTROSURGICAL DISSECTOR; ELECTRODE HANDLE ONLY, W/SUCTION-**Needs B68130 Monopolar Cable**
BLACK & BLACK SURGICAL, INC.
B65300
In Commercial Distribution

  • B089B653000 ()
B65300

  • Open-surgery electrosurgical electrode, monopolar, reusable

 B&B Monopolar Dissector - B089B652280

B&B E-P ELECTROSURGICAL DISSECTOR; 14 5''(36.5CM), STRAIGHT SHAFT, ANGLED TIP
BLACK & BLACK SURGICAL, INC.
B65228
In Commercial Distribution

  • B089B652280 ()
B65228

  • Open-surgery electrosurgical electrode, monopolar, reusable

 B&B Monopolar Dissector - B089B652270

B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT TIP (1 PAIR)
BLACK & BLACK SURGICAL, INC.
B65227
In Commercial Distribution

  • B089B652270 ()
B65227

  • Open-surgery electrosurgical electrode, monopolar, reusable

Echovirus Negative Control - B110ECN44100

No Description
Bion Enterprises, Ltd.
ECN-4410
Not in Commercial Distribution

  • B110ECN44100 ()
ECN-4410

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

Echovirus IgG Control - B110ECG44200

No Description
Bion Enterprises, Ltd.
ECG-4420
Not in Commercial Distribution

  • B110ECG44200 ()
ECG-4420

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

K.T.Surgico - KTS0810214

Operating Scissor B/B 5.5"STR
K.T.SURGICO
2025
Not in Commercial Distribution

  • SCISSORBB01 ()
  • KTS0810214 ()
  • TMS1530014 ()
KTS0810214

  • General-purpose surgical scissors, single-use

Toxigenic C. difficile Direct Test - Sample Prep - G491CDF2SPD0

No Description
Vela Operations USA Inc.
00
In Commercial Distribution

  • G491CDF2SPD0 ()
CDF2-SPD

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Toxigenic C. difficile Direct Test - G491CDF20

No Description
Vela Operations USA Inc.
01
In Commercial Distribution

  • G491CDF21 ()
  • G491CDF20 ()
300786

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

RINN® - D0035409311

RINN® XCP®/BAI #3 Horizontal B/W B/B
Dentsply International Inc.
540931
In Commercial Distribution

  • D0035409310 ()
  • D0035409311 ()
540931

  • Dental x-ray film holder, reusable

Echovirus Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110EC44120

No Description
Bion Enterprises, Ltd.
EC-4412
In Commercial Distribution

  • B110EC44120 ()
EC-4412

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, reagent
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