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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Elite II Rail Clamp w/1 Ins Ca
THOMPSON SURGICAL INSTRUMENTS, INC.
41904AC-B
In Commercial Distribution

  • 00841536140323 ()


  • Surgical retraction system, reusable
Elite II Rail Clamp w/2 Ins Ca
THOMPSON SURGICAL INSTRUMENTS, INC.
41903AC-B
In Commercial Distribution

  • 00841536140316 ()


  • Surgical retraction system, reusable
EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer
MEDICA CORPORATION
7005
In Commercial Distribution

  • 00386100003739 ()
7005

  • Ion-selective analyser IVD
EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer
MEDICA CORPORATION
7001
In Commercial Distribution

  • 00386100002596 ()
7001

  • Ion-selective analyser IVD
5091-122 MICRO BUR,RND,MD,6 FLTS,CA
MEDLINE INDUSTRIES, INC.
5091122R
In Commercial Distribution

  • 20888277388021 ()
  • 10888277388024 ()
5091122R

  • Orthopaedic bur, single-use
NOVA 8 Na+, K+, Ca+, Mg++, pH, Hct
NOVA BIOMEDICAL CORPORATION
8
In Commercial Distribution

  • 00385480151962 ()
15196

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
SKYN Supreme Feel Non-Latex Condom BX16 CA RP
SURETEX LIMITED - BRANCH
08859798106041
In Commercial Distribution

  • 28859798106045 ()
  • 08859798106041 ()


  • Basic male condom, synthetic polymer
NEEDLE HOLDER CRILE WOOD DELICATE 10.0 TUNGSTEN CA
TELEFLEX INCORPORATED
IPN008176
In Commercial Distribution

  • 04026704533428 ()
  • 24026704533422 ()

  • Length: 26.2 Centimeter
510420

  • Suturing needle holder, reusable
4 PUMP HORIZ CARRIER W/CA ELEC STRIP
PRYOR PRODUCTS
2M0815CA
In Commercial Distribution

  • 00761887001947 ()
2M0815CA

  • Freestanding/bed-attached intravenous pole
3 PUMP HORZ CARRIER W/CA ELEC STRIP
PRYOR PRODUCTS
2M0814CA
In Commercial Distribution

  • 00761887001923 ()
2M0814CA

  • Freestanding/bed-attached intravenous pole
6 PUMP VERTICAL CARRIER W/CA ELEC STRIP
PRYOR PRODUCTS
2M0812CA
In Commercial Distribution

  • 00761887001909 ()
2M0812CA

  • Freestanding/bed-attached intravenous pole
4 PUMP VERTICAL CARRIER W/CA ELECTRICAL STRIP
PRYOR PRODUCTS
2M0811CA
In Commercial Distribution

  • 00761887001886 ()
2M0811CA

  • Freestanding/bed-attached intravenous pole
PVC Anesthesia Mask #6, Adult - XL, 80/CA
VENTLAB, LLC
812-0011-01
Not in Commercial Distribution

  • 30889483271081 ()
812-0011-01

  • Anaesthesia face mask, single-use
PVC Anesthesia Mask #5, Adult - L, 100/CA
VENTLAB, LLC
812-0010-01
Not in Commercial Distribution

  • 30889483271074 ()
812-0010-01

  • Anaesthesia face mask, single-use
PVC Anesthesia Mask #4, Adult - M, 100/CA
VENTLAB, LLC
812-0009-01
Not in Commercial Distribution

  • 30889483271067 ()
812-0009-01

  • Anaesthesia face mask, single-use
PVC Anesthesia Mask #3, Adult - S, 150/CA
VENTLAB, LLC
812-0008-01
Not in Commercial Distribution

  • 30889483271043 ()
812-0008-01

  • Anaesthesia face mask, single-use
WYE,BI,W/TEMP ON RIGHT,50/CA
BOUND TREE MEDICAL, LLC
S1137
In Commercial Distribution

  • 00810071638640 ()
  • 00810071638619 ()
301-S1137

  • Y-piece breathing circuit connector, single-use
PEEP VALVE,19MM,MRI,30MM ADAPTER 20/ CA
BOUND TREE MEDICAL, LLC
MRIPEEP-A
In Commercial Distribution

  • 00810071637995 ()
  • 00810071637278 ()
301-MRIPEEP-A

  • PEEP valve, single-use
MASK,OX,AD,NOREBRTH,1VLV,7FT 50/CA
BOUND TREE MEDICAL, LLC
301-181EA
In Commercial Distribution

  • 00810071630835 ()
  • 00810071631238 ()
301-181EA

  • Non-rebreathing oxygen face mask
CANNULA,NEO,SOFT,7'* 25/BX 125/CA
BOUND TREE MEDICAL, LLC
301-122EA
In Commercial Distribution

  • 00810071630682 ()
  • 00810071631085 ()
  • 00810071630958 ()
301-122EA

  • Tracheostomy tube cannula, single-use
Hilo Bath TR 900 CA, With Stainless Bathtub
Tr Equipment AB
05192165-SS
In Commercial Distribution

  • 07350016061773 ()


  • Hydrotherapy bath/tank
Personal Use Kit OC-Auto, for San Diego, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334351
In Commercial Distribution

  • 00816917022024 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Palo Alto, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2334272
In Commercial Distribution

  • 00816917021973 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Loma Linda, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2333714
In Commercial Distribution

  • 00816917021898 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Long Beach, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 220104
In Commercial Distribution

  • 00816917021713 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for VA Livermore, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 918369
In Commercial Distribution

  • 00816917026107 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for West LA, CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 213230
In Commercial Distribution

  • 00816917021416 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Univ CA Urvine
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-UCI
In Commercial Distribution

  • 00816917021317 ()


  • Faecal occult blood IVD, reagent
Broca de seio lateral diamantada CA 3,0 mm
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S0500D
In Commercial Distribution

  • 07908854000661 ()


  • Bone lever/elevator, reusable
277-10-50 EGG BUR,FAST CTNG,10 FLT CA
MEDLINE INDUSTRIES, INC.
2771050RH
In Commercial Distribution

  • 10888277387157 ()
2771050RH

  • Orthopaedic bur, single-use
5091-226 MICRO BUR,RND,MD,8 FLTS,CA
MEDLINE INDUSTRIES, INC.
5091226R
In Commercial Distribution

  • 20888277385105 ()
  • 10888277385108 ()
5091226R

  • Arthroscopic shaver system blade, reprocessed
NEURO-ARM SYSTEM W CLAMP HOLDING ADAPTER
GEOMED Medizin-Technik GmbH & Co. KG
CA 450-40-01
In Commercial Distribution

  • 14049679092957 ()


  • Surgical instrument assist arm system, manually-adjusted
No Description
PROSOMNUS SLEEP TECHNOLOGIES
CA Monitor
In Commercial Distribution

  • 00863039000454 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
MANI DIA-BURS
MANI, INC.
BR-45 CA
In Commercial Distribution

  • 74546951610929 ()
  • 04546951610920 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
EX-122F CA
In Commercial Distribution

  • 74546951610325 ()
  • 04546951610326 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
EX-18 CA
In Commercial Distribution

  • 74546951610271 ()
  • 04546951610272 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
FO-25 CA
In Commercial Distribution

  • 74546951609589 ()
  • 04546951609580 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-82 CA
In Commercial Distribution

  • 74546951608391 ()
  • 04546951608392 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SF-83 CA
In Commercial Distribution

  • 74546951608384 ()
  • 04546951608385 ()


  • Diamond dental bur, reusable
MANI DIA-BURS
MANI, INC.
SI-147 CA
In Commercial Distribution

  • 74546951608346 ()
  • 04546951608347 ()


  • Diamond dental bur, reusable
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