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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Alinity i CA 19-9XR Reagent Kit 200 Tests
Abbott GmbH
08P3221
In Commercial Distribution

  • 00380740155919 ()
08P3221

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
AccuThrive #3 Scalpel Handle with Ruler 5EA/CA
AccuTec, Inc.
Scalpel Handle
In Commercial Distribution

  • 00843382114312 ()
AVSC-2000-0000

  • Scalpel handle, reusable
5092-124 MICRO BUR,RND,LONG,6 FLT CA
MEDLINE INDUSTRIES, INC.
5092124R
In Commercial Distribution

  • 20888277368788 ()
  • 10888277368781 ()
5092124R

  • Orthopaedic bur, single-use
Nautilus Polyaxial Screw CA, 8.5mm x 60mm Cannulated
Life Spine, Inc.
1385-60-5
In Commercial Distribution

  • 00190837053932 ()
1385-60-5

  • Spinal bone screw, non-bioabsorbable
Elite II Rail Clamp w/2 Ins Ca
THOMPSON SURGICAL INSTRUMENTS, INC.
41905AC-B
In Commercial Distribution

  • 00841536140330 ()


  • Surgical retraction system, reusable
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
Hilo Bath TR 900 CA, With Stainless Bathtub
Tr Equipment AB
05192165-SS
In Commercial Distribution

  • 07350016061773 ()


  • Hydrotherapy bath/tank
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
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
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
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
SKYN Supreme Feel Non-Latex Condom BX16 CA RP
SURETEX LIMITED - BRANCH
08859798106041
In Commercial Distribution

  • 28859798106045 ()
  • 08859798106041 ()


  • Basic male condom, synthetic polymer
S3 300DT 2x Sgl 1x Dual CA 2x 1300 1150 1000 CA 3P 30M 9P 30M 2x Barco Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006438 ()
C33SDS554335KK

  • Operating room light
S3 300DT 3x Sgl CA 1xDual CA 1300 1150 1000 1300 2x LCH 3P 1x9P LCH 1x Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003741 ()
C33SDS54354614

  • Operating room light
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB607EW
In Commercial Distribution

  • 08800036204159 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB605EW
In Commercial Distribution

  • 08800036204142 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAIT40435
In Commercial Distribution

  • 08800036204081 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAIT40434
In Commercial Distribution

  • 08800036204074 ()


  • Dental implant system
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Bone cutter CA L 1,6 mm, pu: 1 St.
DFS - DIAMON GmbH
110326
In Commercial Distribution

  • 04057176163288 ()
  • 04057176163295 ()


  • Carbide dental bur, reusable
Bone cutter CA L 1,6 mm, pu: 1 St.
DFS - DIAMON GmbH
110323
In Commercial Distribution

  • 04057176163226 ()
  • 04057176163233 ()


  • Carbide dental bur, reusable
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
Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody
CELL MARQUE CORPORATION
379M-16
In Commercial Distribution

  • 00841683139874 ()


  • Carbonic anhydrase IVD, antibody
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
M Peeso Reamer CA #3 (set of 4 pcs)
DENTECH CORPORATION
02312205
In Commercial Distribution

  • 04560218662866 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
M Peeso Reamer CA #2 (set of 4 pcs)
DENTECH CORPORATION
02312204
In Commercial Distribution

  • 04560218662859 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
M Peeso Reamer CA #1 (set of 4 pcs)
DENTECH CORPORATION
02312203
In Commercial Distribution

  • 04560218662842 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
M Peeso Reamer CA #0 (set of 4 pcs)
DENTECH CORPORATION
02312202
In Commercial Distribution

  • 04560218662835 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
M Peeso Reamer CA #00 (set of 4 pcs)
DENTECH CORPORATION
02312201
In Commercial Distribution

  • 04560218662828 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
M Peeso Reamer CA #000 (set of 4 pcs)
DENTECH CORPORATION
02312200
In Commercial Distribution

  • 04560218662811 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
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
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
CA 125 II Master Curve Material Kit - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310442
In Commercial Distribution

  • 00630414461274 ()
128530

  • Cancer antigen 125 (CA125) IVD, control
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