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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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"Sterile Blue Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility. Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per box."
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-351 B
In Commercial Distribution

  • B21257351B2 ()
  • B21257351B1 ()
  • B21257351B0 ()
57-351 B

  • Syringe tip cap
Sterile Red Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility. Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per box.
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-301 R
In Commercial Distribution

  • B21257301R2 ()
  • B21257301R1 ()
  • B21257301R0 ()
57-301 R

  • Syringe tip cap
"Sterile Blue Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility. Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per box."
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-301 B
In Commercial Distribution

  • B21257301B2 ()
  • B21257301B1 ()
  • B21257301B0 ()
57-301 B

  • Syringe tip cap
Kit Contains: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFB03, 5x100 Kii SH BLD ADVFIX, 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK403
In Commercial Distribution

  • 20607915127880 ()


  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CFF03, 5x100 Kii Fios ADVFIX 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK402
In Commercial Distribution

  • 20607915127873 ()


  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
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
Kit Contains: C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK321
In Commercial Distribution

  • 20607915135601 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Ligation clip, metallic
Kit Contains: C0Q20, 5x100 Kii BALLOON BLUNT TIP 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CTF03, 5x100 Kii Fios Z-THR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK406
In Commercial Distribution

  • 20607915132457 ()


  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CFF03, 5x100 Kii Fios ADVFIX 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK309
In Commercial Distribution

  • 20607915132228 ()


  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-test and 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are: REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
CS-2001-CC-10
In Commercial Distribution

  • 00866479000152 ()


  • Soft-tissue biopsy needle, single-use
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