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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VELOCITY SLB CA ROTH LAT +8T -9A .022 UR
LANCER ORTHODONTICS, INC.
24R-22R
In Commercial Distribution

  • 00817573024582 ()


  • Orthodontic bracket, metal
VELOCITY SLB CA ROTH CEN +12T +5A .022 UL
LANCER ORTHODONTICS, INC.
24R-12L
In Commercial Distribution

  • 00817573024575 ()


  • Orthodontic bracket, metal
VELOCITY SLB CA ROTH CEN +12T +5A .022 UR
LANCER ORTHODONTICS, INC.
24R-12R
In Commercial Distribution

  • 00817573024568 ()


  • Orthodontic bracket, metal
GLOVE,EXAM,CA,4G VINYL, CHEMO,PF,LF,S
MEDLINE INDUSTRIES, INC.
64GVINSC
In Commercial Distribution

  • 10193489136692 ()
  • 00193489136732 ()
  • 20193489136699 ()
64GVINSC

  • Vinyl examination/treatment glove, non-powdered
CANNULA,ADL,CURVED,FOAM,14',STD CONN,25/CA
TRI-ANIM HEALTH SERVICES, INC.
301-PUCS114
In Commercial Distribution

  • 00818834022293 ()
  • 00818834021210 ()
301-PUCS114

  • Nasal oxygen cannula, basic
NUT/NIPPLE,OX,TAPER,SWIVEL 50/BG 500/CA
TRI-ANIM HEALTH SERVICES, INC.
301-195EA
In Commercial Distribution

  • 00818834022095 ()
  • 00818834021555 ()
  • 00818834021012 ()
301-195EA

  • Rebreathing oxygen face mask
BANTAM SM CHUCK HANDLE AS SY WITH 10FT CA
Gyrus ACMI, LLC
5205007
In Commercial Distribution

  • 00821925009646 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
CS1-CH04,Contra Angle, Latch Type, CA Burs, 1:1
Beyes Dental Canada Inc
SL2028
In Commercial Distribution

  • 00837699000680 ()


  • Dental power tool handpiece motorless component
CS1-CH02,Contra Angle, Push Botton, CA Burs, 1:1
Beyes Dental Canada Inc
SL2026
In Commercial Distribution

  • 00837699000673 ()


  • Dental power tool handpiece motorless component
VITROS Immunodiagnostic Products CA 125 II™ Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6800880
In Commercial Distribution

  • 10758750001002 ()
  • 20758750001009 ()
6800880

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CS1-CH04,Contra Angle, Latch Type, CA Burs, 1:1
Beyes Dental Canada Inc
SL2028
In Commercial Distribution

  • 00990010301870 ()
CS1-CH04

  • Dental power tool handpiece motorless component
CS1-CH02,Contra Angle, Push Botton, CA Burs, 1:1
Beyes Dental Canada Inc
SL2026
In Commercial Distribution

  • 00990010301863 ()
CS1-CH02

  • Dental power tool handpiece motorless component
Roth .022 Hks 3's, anteriors .018, 6X6 CA
World Class Technology Corporation
905.2035
In Commercial Distribution

  • 00840273916765 ()
905.2035

  • Orthodontic bracket, metal
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody
CELL MARQUE CORPORATION
379M-16
In Commercial Distribution

  • 00841683139874 ()


  • Carbonic anhydrase IVD, antibody
ERBOCRYO® CA Cryosurgical System, 120 V/60Hz, UL
Erbe Elektromedizin GmbH
10448-004
In Commercial Distribution

  • 04050147019737 ()
10448-004

  • General cryosurgical system, cryogen gas, mechanical
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody
CELL MARQUE CORPORATION
379M-15
In Commercial Distribution

  • 00841683139867 ()


  • Carbonic anhydrase IVD, antibody
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody
CELL MARQUE CORPORATION
379M-14
In Commercial Distribution

  • 00841683139850 ()


  • Carbonic anhydrase IVD, antibody
35 Degree Bracket for Esaote CA 621 Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
6355
In Commercial Distribution

  • 00841912102204 ()


  • Ultrasound imaging system tracking positioner, reusable
25 Degree Bracket for Esaote CA 621 Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
6354
In Commercial Distribution

  • 00841912102198 ()


  • Ultrasound imaging system tracking positioner, reusable
Bioprocessing Phosphate Buffer without Ca+2 and Mg+2
Incell Corporation, LLC
ZSOLF0500
In Commercial Distribution

  • G507ZSOLF05000 ()

  • Total Volume: 500 Milliliter
ZSOLF0500

  • Cell culture medium IVD
LOCI CA 19-9 Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10464358
In Commercial Distribution

  • 00842768028533 ()
  • 00630414005621 ()
K6457

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
LOCI CA 15-3 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464344
In Commercial Distribution

  • 00842768028526 ()
  • 00630414005591 ()
K6456

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
LOCI CA 125 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464357
In Commercial Distribution

  • 00842768028519 ()
  • 00630414005614 ()
K6455

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
6 LEG 3 PUMP ADAPTER W/CA ELEC STRIP
PRYOR PRODUCTS
2M0809CA
In Commercial Distribution

  • 00761887001862 ()
2M0809CA

  • Freestanding/bed-attached intravenous pole
CA ONLY,GLOVE,EXAM,STRCH,VINYL,PF,LF,XL
MEDLINE INDUSTRIES, INC.
6MSV604
In Commercial Distribution

  • 40888277305558 ()
  • 30888277305551 ()
  • 10888277305557 ()
6MSV604

  • Vinyl examination/treatment glove, non-powdered
CA ONLY,GLOVE,EXAM,STRETCH,VINYL,PF,LF,L
MEDLINE INDUSTRIES, INC.
6MSV603
In Commercial Distribution

  • 40888277305541 ()
  • 30888277305544 ()
  • 10888277305540 ()
6MSV603

  • Vinyl examination/treatment glove, non-powdered
CA ONLY,GLOVE,EXAM,STRETCH,VINYL,PF,LF,S
MEDLINE INDUSTRIES, INC.
6MSV601
In Commercial Distribution

  • 40888277305527 ()
  • 30888277305520 ()
  • 10888277305526 ()
6MSV601

  • Vinyl examination/treatment glove, non-powdered
IntelliPAP AutoBilevel w/HH & SmartLink II, Module & Data Ca
DEVILBISS HEALTHCARE LLC
DV57D-HH-S2
Not in Commercial Distribution

  • 00885304009535 ()
  • 10885304009532 ()
DV57D-HH-S2

  • Home CPAP unit
Nautilus Assembly CA, Ø7.5 x45 Long x 5 Lead
Life Spine, Inc.
375-45-5
In Commercial Distribution

  • 00190837057091 ()
375-45-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø7.5 x40 Long x 5 Lead
Life Spine, Inc.
375-40-5
In Commercial Distribution

  • 00190837057077 ()
375-40-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø7.5 x35 Long x 5 Lead
Life Spine, Inc.
375-35-5
In Commercial Distribution

  • 00190837057053 ()
375-35-5

  • Bone-screw internal spinal fixation system, non-sterile
Personal Use Kit OC-Auto, for LabCorp San Diego CA
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-LBCP SDCA
In Commercial Distribution

  • 00816917020563 ()


  • Faecal occult blood IVD, reagent
Rhino XE CA 1:1 PB Latch Chuck E-Type
SIRONA Dental Systems GmbH
710485
In Commercial Distribution

  • E2767104850 ()


  • Dental power tool handpiece motorless component
3 mL syringe Light cure cavity liner
PULPDENT CORPORATION
LIME3
Not in Commercial Distribution

  • D701LIME32 ()

  • Total Volume: 3 Milliliter


  • Calcium hydroxide dental cement
  • Calcium hydroxide dental suspension
Kit: 4 x 1.2 mL syringes + 8 applicator tips Light curve cavity liner
PULPDENT CORPORATION
LIME
Not in Commercial Distribution

  • D701LIME2 ()

  • Total Volume: 1.2 Milliliter


  • Calcium hydroxide dental cement
  • Calcium hydroxide dental suspension
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA 7.0
Not in Commercial Distribution

  • 00862487000320 ()

  • Weight: 7.0 Gram
None

  • Glass ionomer dental cement
  • Endodontic filling/sealing material
SPRING CLIP,SAFEJAW 6MM STER FOGARTY,LATEX FREE 10/CA
Edwards Lifesciences LLC
CSAFE6
In Commercial Distribution

  • 00690103044164 ()
  • 70690103044163 ()

  • MAXIMUM JAW OPENING: 6MM
CSAFE6

  • Vascular clamp, single-use
S1 300DT DUAL CA 850 700 2x 3P DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003215 ()
C13D2133

  • Operating room light
S3 300DT 3xSgl CA 1300,1300,1150 2x MH1 LCH 1x9P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003192 ()
C33SSS554116

  • Operating room light
S1 200DT Sgl CA 1150mm Camera spring arm 9P 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001983 ()
C12S45

  • Operating room light
S1 700 DT 1150mm 1000mm CA 2x 3P DY i30
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706006827 ()
C17D43EE

  • Operating room light
S1 200DT Dual CA 1150 1000 i30 DY Sgl MH
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706003659 ()
C12D43E1

  • Operating room light
S1 700DT Dual CA 1150 1000 3P SL-30M sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007558 ()
C17D4331

  • Operating room light
S1 200DT 1000 700 CA 3P DY 30M SGL MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007077 ()
C12D3131

  • Operating room light
Series 1 1000 DT Sgl CA 1300mm 3P DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006681 ()
C11S53

  • Operating room light
Series 1 1000 DT Sgl CA 1300mm 3P DY i30
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006582 ()
C11S5E

  • Operating room light
S1 200DT 850 700 CA 3P DY 30M SGL MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006469 ()
C12D2131

  • Operating room light
Series 1 200DT Sgl CA 1300mm 3P DY Gen1 i30
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006414 ()
C12S5E

  • Operating room light
S1 300DT Sgl CA 1150mm Camera spring arm 9P 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006377 ()
C13S45

  • Operating room light
Series 1 200DT Sgl CA 1150mm 3P DY Gen1 i30
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706006292 ()
C12S4E

  • Operating room light
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