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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Tip 1UQ with tip changer
W & H Dentalwerk Bürmoos GmbH
08023920
In Commercial Distribution

  • J021080239201 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1ES with spanner
W & H Dentalwerk Bürmoos GmbH
07983880
In Commercial Distribution

  • J021079838801 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 4PS with tip changer
W & H Dentalwerk Bürmoos GmbH
07983870
In Commercial Distribution

  • J021079838701 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1PS with tip changer
W & H Dentalwerk Bürmoos GmbH
07983860
In Commercial Distribution

  • J021079838601 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3US with changer
W & H Dentalwerk Bürmoos GmbH
07983850
In Commercial Distribution

  • J021079838501 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 2US with tip changer
W & H Dentalwerk Bürmoos GmbH
07983830
In Commercial Distribution

  • J021079838301 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1US with tip changer
W & H Dentalwerk Bürmoos GmbH
07983820
In Commercial Distribution

  • J021079838201 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 4P with tip changer
W & H Dentalwerk Bürmoos GmbH
07965670
In Commercial Distribution

  • J021079656701 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 5Pr with tip changer
W & H Dentalwerk Bürmoos GmbH
07965660
In Commercial Distribution

  • J021079656601 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 5Pl with tip changer
W & H Dentalwerk Bürmoos GmbH
07965620
In Commercial Distribution

  • J021079656201 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 5P with tip changer
W & H Dentalwerk Bürmoos GmbH
07965600
In Commercial Distribution

  • J021079656001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 6E with spanner
W & H Dentalwerk Bürmoos GmbH
07812500
In Commercial Distribution

  • J021078125001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 5E with tip changer
W & H Dentalwerk Bürmoos GmbH
07812400
In Commercial Distribution

  • J021078124001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 4E with spanner
W & H Dentalwerk Bürmoos GmbH
07812300
In Commercial Distribution

  • J021078123001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip Set for Proxeo ULTRA
W & H Dentalwerk Bürmoos GmbH
07812200
In Commercial Distribution

  • J021078122001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
No Description
W & H Dentalwerk Bürmoos GmbH
07159900
In Commercial Distribution

  • J021071599001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
No Description
W & H Dentalwerk Bürmoos GmbH
07159800
In Commercial Distribution

  • J021071598001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Synea Sonic Scaler Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
07159700
In Commercial Distribution

  • J021071597001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Synea Sonic Scaler Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
07009100
In Commercial Distribution

  • J021070091001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip Set for Proxeo ULTRA
W & H Dentalwerk Bürmoos GmbH
06370500
In Commercial Distribution

  • J021063705001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3Rd with tip changer
W & H Dentalwerk Bürmoos GmbH
06368600
In Commercial Distribution

  • J021063686001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3Rm with tip changer
W & H Dentalwerk Bürmoos GmbH
06368500
In Commercial Distribution

  • J021063685001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 2R with tip changer
W & H Dentalwerk Bürmoos GmbH
06368400
In Commercial Distribution

  • J021063684001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3E with spanner
W & H Dentalwerk Bürmoos GmbH
06368100
In Commercial Distribution

  • J021063681001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 2E with spanner
W & H Dentalwerk Bürmoos GmbH
06368000
In Commercial Distribution

  • J021063680001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1E with spanner
W & H Dentalwerk Bürmoos GmbH
06367900
In Commercial Distribution

  • J021063679001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3Pl with tip changer
W & H Dentalwerk Bürmoos GmbH
06365000
In Commercial Distribution

  • J021063650001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3Pr with tip changer
W & H Dentalwerk Bürmoos GmbH
06364900
In Commercial Distribution

  • J021063649001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1I with tip changer
W & H Dentalwerk Bürmoos GmbH
06364500
In Commercial Distribution

  • J021063645001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip Set for Proxeo ULTRA
W & H Dentalwerk Bürmoos GmbH
05851800
In Commercial Distribution

  • J021058518001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1R with tip changer
W & H Dentalwerk Bürmoos GmbH
05849401
In Commercial Distribution

  • J021058494011 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 4U with tip changer
W & H Dentalwerk Bürmoos GmbH
05849201
In Commercial Distribution

  • J021058492011 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1P with tip changer
W & H Dentalwerk Bürmoos GmbH
05370400
In Commercial Distribution

  • J021053704001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 3U with tip changer
W & H Dentalwerk Bürmoos GmbH
05368200
In Commercial Distribution

  • J021053682001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 2U with tip changer
W & H Dentalwerk Bürmoos GmbH
05076300
In Commercial Distribution

  • J021050763001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Tip 1U with tip changer
W & H Dentalwerk Bürmoos GmbH
05076200
In Commercial Distribution

  • J021050762001 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Dental magnetostrictive scaler 18 K, with four (4) M series tips (2 - M1 and 2 M2 or M4) insert and nose cone.
ENGLER ENGINEERING CORPORATION
Sonus V
In Commercial Distribution

  • 00862872000355 ()

  • Length: 9 Inch
  • Width: 7.5 Inch
  • Height: 3 Inch
  • Weight: 8 Pound
A52000

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
No Description
Biomet Orthopedics, LLC
110027858
In Commercial Distribution

  • 00880304806412 ()

  • 25 MM 25 MM
110027858

  • Orthopaedic bone staple, non-adjustable
DIST, LEFORT 1, TSMD, L PLATE, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-542-15-09
In Commercial Distribution

  • 00888118127808 ()

  • 25 MM, 25 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, TSMD, L PLATE, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-542-05-09
In Commercial Distribution

  • 00888118127792 ()

  • 25 MM, 25 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, TSMD, L PLATE, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-473-39-02
In Commercial Distribution

  • 00888118101143 ()

  • 25 MM, 25 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, TSMD, L PLATE, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-473-39-01
In Commercial Distribution

  • 00888118101136 ()

  • 25 MM, 25 HOLE


  • Implantable craniofacial bone distractor
Surgical Mask Tie-on Blue ASTM Level 3, 50/BX,1000/CS, 25/25/25
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 00683534090220 ()
  • 00683534090237 ()
  • 80683534090226 ()
68-8538-B

  • Surgical/medical face mask, non-antimicrobial, single-use
Procedure Mask Earloop Green ASTM Level 3, 50/BX,1000/CS, 25/25/25
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 00683534090206 ()
  • 00683534090213 ()
  • 80683534090202 ()
68-8508-G

  • Surgical/medical face mask, non-antimicrobial, single-use
Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
25 Single Service SteriTatt Markers and 25 sterile needles
Flow X Ray Corporation
90002
In Commercial Distribution

  • 00843696195014 ()
  • 30843696195015 ()


  • Tattoo ink, dermal
VITOM® 25 Telescope 0°, AA 25 - 75 cm
Karl Storz GmbH & Co. KG
20916020
In Commercial Distribution

  • 04048551241509 ()


  • Surgical microscope video camera, sterilizable
LoneStar Disposable Retractor Ring - 25 cm x 25 cm
Coopersurgical, Inc.
3310G
In Commercial Distribution

  • 00888937015409 ()

  • Outer Diameter: 25 Centimeter


  • Surgical retraction system mounting frame, single-use
Test for in-house patient: 25 Cassettes + 25 Collection Tubes
WONDFO USA CO., LTD.
PRE-FIT-25A
In Commercial Distribution

  • 10816862021568 ()
  • 00816862021561 ()
  • 00816862028560 ()


  • Faecal occult blood IVD, kit, rapid ICT, clinical
25 strips - 80883489002415
BIONIME CORPORATION
Diathrive+ Blood Glucose Test Strip
In Commercial Distribution

  • 20883489002420 ()
  • 10883489002423 ()
  • 00883489002426 ()
  • 00883489002419 ()
  • 80883489002415 ()
99GS280D51

  • Glucose monitoring system IVD, home-use
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