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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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12-Pack: Ivory No. 11
E. Hahnenkratt GmbH
40X11
In Commercial Distribution

  • E20640X1101 ()
  • E20640X110 ()


  • Dental matrix band, reusable
12-Pack: Nyström No. 1
E. Hahnenkratt GmbH
40X1
In Commercial Distribution

  • E20640X11 ()
  • E20640X10 ()


  • Dental matrix band, reusable
12-Pack: Tofflemire No. 103
E. Hahnenkratt GmbH
40X103
In Commercial Distribution

  • E20640X1031 ()
  • E20640X1030 ()


  • Dental matrix band, reusable
12-Pack: Tofflemire No. 102
E. Hahnenkratt GmbH
40X102
In Commercial Distribution

  • E20640X1021 ()
  • E20640X1020 ()


  • Dental matrix band, reusable
12-Pack: Tofflemire No. 101
E. Hahnenkratt GmbH
40X101
In Commercial Distribution

  • E20640X1011 ()
  • E20640X1010 ()


  • Dental matrix band, reusable
Air Motor
W & H Dentalwerk Bürmoos GmbH
30109000
In Commercial Distribution

  • J021301090000 ()
  • J021301090001 ()


  • Dental surgical power tool motor, pneumatic
Air Motor
W & H Dentalwerk Bürmoos GmbH
30107000
In Commercial Distribution

  • J021301070000 ()
  • J021301070001 ()


  • Dental surgical power tool motor, pneumatic
Air Motor
W & H Dentalwerk Bürmoos GmbH
30105000
In Commercial Distribution

  • J021301050001 ()


  • Dental surgical power tool motor, pneumatic
Air Motor
W & H Dentalwerk Bürmoos GmbH
11042500
Not in Commercial Distribution

  • J021110425000 ()
  • J021110425001 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
Surgical Handpiece
W & H Dentalwerk Bürmoos GmbH
10207550
In Commercial Distribution

  • J021102075500 ()
  • J021102075501 ()


  • Dental surgical power tool motorized handpiece/set, electric
Surgical Mesh
SPINEOLOGY INC.
10-10-04-15
In Commercial Distribution

  • M7403302705 ()

  • Length: 31 Millimeter
330-2705

  • Vertebral body bone graft pouch
Surgical Mesh
SPINEOLOGY INC.
10-10-04-6
In Commercial Distribution

  • M7403302505 ()

  • Length: 30 Millimeter
330-2505

  • Vertebral body bone graft pouch
Surgical Mesh
SPINEOLOGY INC.
10-10-04-9
In Commercial Distribution

  • M7403302205 ()

  • Length: 27 Millimeter
330-2205

  • Vertebral body bone graft pouch
Surgical Mesh
SPINEOLOGY INC.
10-10-04-8
In Commercial Distribution

  • M7403302005 ()

  • Length: 25 Millimeter
330-2005

  • Vertebral body bone graft pouch
Surgical Mesh
SPINEOLOGY INC.
10-10-04-7
In Commercial Distribution

  • M7403301805 ()

  • Length: 23 Millimeter
330-1805

  • Vertebral body bone graft pouch
No Description
KaVo Dental GmbH
1.003.6976
In Commercial Distribution

  • EKAV100369760 ()
31 E

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.003.1108
In Commercial Distribution

  • EKAV100311080 ()
14 E

  • Dental surgical power tool motor, electric
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.6403
In Commercial Distribution

  • EKAV100464030 ()
19 E

  • Dental power tool system handpiece, line-powered
This is a medical device.This is a medical device.
KaVo Dental GmbH
1.004.6401
In Commercial Distribution

  • EKAV100464010 ()
80 E

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.003.6977
In Commercial Distribution

  • EKAV100369770 ()
10 E

  • Dental power tool system handpiece, line-powered
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered
No Description
Biomet Orthopedics, LLC
110010222
In Commercial Distribution

  • 00880304568600 ()

  • E 28/32/36MM
110010222

  • Joint prosthesis implantation kit, reusable
No Description
Biomet Orthopedics, LLC
31-311345
In Commercial Distribution

  • 00880304675933 ()

  • SIZE E 80MM STANDARD
31-311345

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-311325
In Commercial Distribution

  • 00880304675797 ()

  • SIZE E 70MM STANDARD
31-311325

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
42-5380-005-02
In Commercial Distribution

  • 00880304812697 ()

  • Size E RIGHT Medial
42-5380-005-02

  • Uncoated unicondylar knee tibia prosthesis, metallic
No Description
Biomet Orthopedics, LLC
42-5380-005-01
In Commercial Distribution

  • 00880304812680 ()

  • Size E LEFT Medial
42-5380-005-01

  • Uncoated unicondylar knee tibia prosthesis, metallic
No Description
Zimmer, Inc.
20113605
In Commercial Distribution

  • 00889024519039 ()

  • Lumen/Inner Diameter: 36.00 Millimeter
  • 10 Degree, Size E
20113605

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
20113205
In Commercial Distribution

  • 00889024518988 ()

  • Lumen/Inner Diameter: 32.00 Millimeter
  • 10 Degree, Size E
20113205

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
20112805
In Commercial Distribution

  • 00889024518926 ()

  • 10 Degree, Size E
  • Lumen/Inner Diameter: 28.00 Millimeter
20112805

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
42-5870-071-02
In Commercial Distribution

  • 00889024551046 ()

  • Size E, 0 Degree
42-5870-071-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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