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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Mixing Bowl, Medium, 350cc, Yellow
PLASDENT CORPORATION
904MBM-3C
In Commercial Distribution

  • D832904MBM3C0 ()
904MBM-3C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Blue
PLASDENT CORPORATION
904MBM-2C
In Commercial Distribution

  • D832904MBM2C0 ()
904MBM-2C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Orange
PLASDENT CORPORATION
904MBM-12C
In Commercial Distribution

  • D832904MBM12C0 ()
904MBM-12C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Purple
PLASDENT CORPORATION
904MBM-10C
In Commercial Distribution

  • D832904MBM10C0 ()
904MBM-10C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Dark Green
PLASDENT CORPORATION
904MB-M
In Commercial Distribution

  • D832904MBM0 ()
904MB-M

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Pink
PLASDENT CORPORATION
904MBL-6C
In Commercial Distribution

  • D832904MBL6C0 ()
904MBL-6C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Red
PLASDENT CORPORATION
904MBL-5C
In Commercial Distribution

  • D832904MBL5C0 ()
904MBL-5C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Green
PLASDENT CORPORATION
904MBL-4C
In Commercial Distribution

  • D832904MBL4C0 ()
904MBL-4C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Yellow
PLASDENT CORPORATION
904MBL-3C
In Commercial Distribution

  • D832904MBL3C0 ()
904MBL-3C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Blue
PLASDENT CORPORATION
904MBL-2C
In Commercial Distribution

  • D832904MBL2C0 ()
904MBL-2C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Orange
PLASDENT CORPORATION
904MBL-12C
In Commercial Distribution

  • D832904MBL12C0 ()
904MBL-12C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Purple
PLASDENT CORPORATION
904MBL-10C
In Commercial Distribution

  • D832904MBL10C0 ()
904MBL-10C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Large, 600cc, Dark Green
PLASDENT CORPORATION
904MB-L
In Commercial Distribution

  • D832904MBL0 ()
904MB-L

  • Dental material mixing surface, chairside, reusable
Silicone Mini Bowls, Small, 8cc
PLASDENT CORPORATION
901MB-S
In Commercial Distribution

  • D832901MBS0 ()
  • D832901MBS1 ()
901MB-S

  • Dental material mixing surface, chairside, reusable
Silicone Mini Bowls, Medium, 30cc
PLASDENT CORPORATION
901MB-M
In Commercial Distribution

  • D832901MBM0 ()
  • D832901MBM1 ()
901MB-M

  • Dental material mixing surface, chairside, reusable
Universal Material Well, Light Gray
PLASDENT CORPORATION
400AW-9L
In Commercial Distribution

  • D832400AW9L0 ()
400AW-9L

  • Dental material mixing surface, chairside, reusable
Universal Material Well, Orange Yellow
PLASDENT CORPORATION
400AW-7X
In Commercial Distribution

  • D832400AW7X0 ()
400AW-7X

  • Dental material mixing surface, chairside, reusable
Universal Material Well, Green Grass
PLASDENT CORPORATION
400AW-4X
In Commercial Distribution

  • D832400AW4X0 ()
400AW-4X

  • Dental material mixing surface, chairside, reusable
Universal Material Well, Blue Ocean
PLASDENT CORPORATION
400AW-2P
In Commercial Distribution

  • D832400AW2P0 ()
400AW-2P

  • Dental material mixing surface, chairside, reusable
Universal Material Well, Black Knight
PLASDENT CORPORATION
400AW-11
In Commercial Distribution

  • D832400AW110 ()
400AW-11

  • Dental material mixing surface, chairside, reusable
Universal Material Well, Purple Gala
PLASDENT CORPORATION
400AW-10P
In Commercial Distribution

  • D832400AW10P0 ()
400AW-10P

  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
470
In Commercial Distribution

  • D8384708 ()
  • D8384706 ()
  • D8384704 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
460
In Commercial Distribution

  • D8384608 ()
  • D8384606 ()
  • D8384604 ()


  • Dental material mixing surface, chairside, reusable
Maxima Advanced Capsule Mixer
HENRY SCHEIN, INC.
5703868
In Commercial Distribution

  • 00304040186084 ()
5703868

  • Dental impression material mixer
3M™ Pentamix™ Lite Automatic Mixing Unit - 120V/60Hz NA, 77907
3M Deutschland GmbH
77907
In Commercial Distribution

  • 04054596646339 ()
77907

  • Dental impression material mixer
3M™ Impregum™ Penta™ Soft Quick Step Medium Body Cartridge for Pentamix™ 3 - Medium Purple, P3776
3M COMPANY
P3776
In Commercial Distribution

  • 04054596736382 ()
P3776

  • Dental impression material mixer
3M™ Pentamix™ 3 Automatic Mixing Unit, 77876
3M Deutschland GmbH
77876
In Commercial Distribution

  • 04054596735729 ()
77876

  • Dental impression material mixer
Mixing Bowl, stainless steel
A. TITAN INSTRUMENTS, INC.
MB-1
In Commercial Distribution

  • 00841685108724 ()


  • Dental material mixing surface, chairside, reusable
No Description
IMEDICOM CO., LTD.
MCX-00
In Commercial Distribution

  • 08809317171029 ()


  • Manual orthopaedic cement mixer, single-use
Maxima Core Capsule Mixer
HENRY SCHEIN, INC.
5703869
In Commercial Distribution

  • 00304040186091 ()
5703869

  • Dental impression material mixer
Alginate Mixer
HENRY SCHEIN, INC.
1126736
In Commercial Distribution

  • 00304040058084 ()
1126736

  • Manual orthopaedic cement mixer, reusable
Vortex Mixer Tube Mini
HENRY SCHEIN, INC.
1126913
In Commercial Distribution

  • 00304040043394 ()
1126913

  • Vortex mixer IVD
No Description
Joline GmbH & Co. KG
US9610
In Commercial Distribution

  • 04250203940917 ()


  • Manual orthopaedic cement mixer, single-use
Maxima Capsule Mixer
HENRY SCHEIN, INC.
5700484
In Commercial Distribution

  • 00304040117422 ()
5700484

  • Dental impression material mixer
CAPSULE MIXER CM-II, AC adaptor and power cord
Gc America Inc.
003680
In Commercial Distribution

  • D0470036801 ()
003680

  • Dental impression material mixer
PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.
Heraeus Medical GmbH
DUO
In Commercial Distribution

  • 04260102133617 ()
  • 04260102133631 ()
  • 04260102133624 ()
66057897

  • Manual orthopaedic cement mixer, single-use
The Pro Nozzle short with knee pressurizer is used in combination with the Pro bone cement system
Heraeus Medical GmbH
66057202
In Commercial Distribution

  • 04260102133105 ()
  • 04260102133099 ()


  • Manual orthopaedic cement mixer, reusable
ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.
OSARTIS GmbH
02-0601
In Commercial Distribution

  • 04260056881572 ()
  • 04260056881565 ()
02-0602

  • Manual orthopaedic cement mixer, single-use
VORTEX CEMENT GUN
Smith & Nephew, Inc.
71272001
In Commercial Distribution

  • 03596010515018 ()
71272001

  • Manual orthopaedic cement mixer, reusable
BISCO LIGHT PROOF RESINVOIR
BISCO INC.
X-80494B
Not in Commercial Distribution

  • D757X80494B1 ()
X-80494B

  • Dental material mixing surface, chairside, reusable
Mixing Wells ACE
BISCO INC.
MXWL-002
Not in Commercial Distribution

  • D757MXWL0020 ()
MXWL-002

  • Dental material mixing surface, chairside, reusable
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
00-5049-045-01
In Commercial Distribution

  • 00889024374850 ()
00-5049-045-01

  • Manual orthopaedic cement mixer, single-use
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
00-5049-035-01
In Commercial Distribution

  • 00889024374843 ()
00-5049-035-01

  • Manual orthopaedic cement mixer, single-use
ACE MIXING WELLS-WHITE-12 PKG
BISCO INC.
X-80498B
Not in Commercial Distribution

  • D757X80498B1 ()
X-80498B

  • Dental material mixing surface, chairside, reusable
No Description
COSMEDENT, INC.
901101
In Commercial Distribution

  • D77990110114 ()


  • Dental material mixing surface, chairside, reusable
STEEL MIXING BOWL 1P
Peter Brasseler Holdings, LLC
5025500U0
In Commercial Distribution

  • 00887919761174 ()


  • Dental material mixing surface, chairside, reusable
Ceramic Mixing Dish for C&B MetaBond®
PARKELL, INC.
S385
In Commercial Distribution

  • 00810000529186 ()
S387

  • Dental material mixing surface, chairside, reusable
3 Bone Cement Mixer with Small Spatula
STRYKER CORPORATION
0206020000
In Commercial Distribution

  • 37613154358336 ()
  • 07613154358335 ()
0206020000

  • Manual orthopaedic cement mixer, reusable
Slim Nozzle [Accessory for Bone Cement Mixing System]
Guangzhou Clean Medical Products Manufacturing Corp.
CL006-06-18E
In Commercial Distribution

  • 06951233721795 ()


  • Manual orthopaedic cement mixer, single-use
Large Nozzle [Accessory for Bone Cement Mixing System]
Guangzhou Clean Medical Products Manufacturing Corp.
CL006-06-17E
In Commercial Distribution

  • 06951233721788 ()


  • Manual orthopaedic cement mixer, single-use
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