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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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CNGL3 - ALBRECHT - 30607915130481

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM
APPLIED MEDICAL RESOURCES CORPORATION
CK399
In Commercial Distribution

  • 30607915130481 ()


  • Laparoscopic multi-instrument access port, single-use
  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic

CNGL2-WHEELER - 30607915129829

Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
CK391
In Commercial Distribution

  • 30607915129829 ()


  • Tissue extraction bag
  • Laparoscopic multi-instrument access port, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic

AM- CHOLE KIT- PORT MAC Q - 30607915120499

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0592
In Commercial Distribution

  • 30607915120499 ()


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

ARONIS LAP CHOLE - 30607915133536

Kit Contains: CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
CK411
In Commercial Distribution

  • 30607915133536 ()


  • Laparoscopic multi-instrument access port, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Ligation clip, metallic

Lap Port Closure Device Kit with10/12mm and 15mm Guides - B354OSLPCDK15

Lap Port Closure Device Kit with10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK15
In Commercial Distribution

  • B354OSLPCDK15 ()
OSLPCDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated

3 Ring Suture Passer Kit with 10/12mm and 15mm Guides - B354OS3CDK15

3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK15 ()
OS3CDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated

Lap Chole Procedure Pack - 20607915136745

Kit Includes: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD003, 5mm Inzii RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK148
In Commercial Distribution

  • 20607915136745 ()


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

LAP CHOLE PROCEDURE PACK - 20607915136691

Kit Contains: CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CFF33, 11X100 Kii Fios ADVFIX 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK137
In Commercial Distribution

  • 20607915136691 ()


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

LAP CHOLE PROCEDURE PACK - 20607915136684

Kit Contains: CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CFS02, 5x100 Kii SLEEVE ADVFIX 12/BX CFF12, 5x100 Kii Fios ADVFIX DP 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK136
In Commercial Distribution

  • 20607915136684 ()


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

LAP CHOLE PROCEDURE PACK - 20607915136592

Kit Contains: CA090, DIRECT DRIVE LCA 3/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK135
Not in Commercial Distribution

  • 20607915136592 ()


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