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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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MEDSTREAM - 10886704064930

Programmable Infusion System Includes: MEDSTREAM Pump;Pump Catheter;Operating Room Prep Kit;Pump Documentation and Information Manual
Cerenovus, Inc.
91-4201US
Not in Commercial Distribution

  • 10886704064930 ()
91-4201US

  • General-purpose implantable infusion pump, programmable

MEDSTREAM - 10886704064923

Programmable Infusion System Includes: MEDSTREAM Pump;Pump Catheter;Operating Room Prep Kit;Pump Documentation and Information Manual
Cerenovus, Inc.
91-4200US
Not in Commercial Distribution

  • 10886704064923 ()
91-4200US

  • General-purpose implantable infusion pump, programmable

Phasor Drill - M710PH635700

2 Flute Drill Bit.
BIOTEX, INC.
008-1042
Not in Commercial Distribution

  • M710PH635700 ()

  • 70 mm usable length
  • Outer Diameter: 6.35 Millimeter
PH-635-70

  • Craniotomy power tool system, battery-powered, single-use

Liofilchem MTS (MIC Test Strip) - 08055182872879

MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 10 Strip
In Commercial Distribution

  • 18055182872876 ()
  • 08055182872879 ()
  • 08055182872855 ()
$92103-10

  • Penicillin G minimum inhibitory concentration (MIC) IVD

PRAS Dilution Blanks - 00810048901197

AS-910 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-910
In Commercial Distribution

  • 00810048902385 ()
  • 00810048901197 ()
AS-910

  • Buffered sample diluent IVD, manual

DR. SCHEER'S BIG LAP CHOLE PACK - 30607915133963

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C4119, 32CM GRASPER REPOS CART, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2680
In Commercial Distribution

  • 30607915133963 ()


  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic

CHOLE KIT 23 - 20607915133287

Kit Contains: C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CTR33, 11X100 Kii OPT ZTHR 6/BX CTR03, 5x100 Kii OPT ZTHR 6/BX CA090, DIRECT DRIVE LCA 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK334
In Commercial Distribution

  • 20607915133287 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic irrigation/aspiration cannula
  • Ligation clip, metallic

KIT KE087 VESICULA LAP - 20607915129440

Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK217
In Commercial Distribution

  • 20607915129440 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic

CHOLE KIT 1 - 20607915128832

Kit Contains: CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX C0R95, 12x100 Kii BLUNT TIP SM CONE 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK307
In Commercial Distribution

  • 20607915128832 ()


  • Tissue extraction bag
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic

SubQ It! - 00867469000206

SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
OPUS KSD, INC.
404010
In Commercial Distribution

  • 00867469000206 ()
  • 10867469000203 ()


  • Skin stapler
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