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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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DENALI MI Spinal System - 10888857000537

Cannulated Power Driver, Jacobs Chuck Attachment
K2M, INC.
1001-90065
In Commercial Distribution

  • 10888857000537 ()
1001-90065

  • General internal orthopaedic fixation system implantation kit

WHITESTAR SIGNATURE - 05050474547735

REMOTE CONTL LOW POWER, WS REFURBISHED
JOHNSON & JOHNSON SURGICAL VISION, INC.
NGP680136R
In Commercial Distribution

  • 05050474547735 ()
NGP680136R

  • Phacoemulsification system

Power Dental USA - D9431601BT0

X POWER TITANIUM BLACK GR1/2
Power Dental U.S.A. Inc.
1601BT
In Commercial Distribution

  • D9431601BT0 ()
1601BT

  • Periodontal curette

Power Dental USA - D9431203BT0

X POWER TITANIUM BLACK H5/33
Power Dental U.S.A. Inc.
1203BT
In Commercial Distribution

  • D9431203BT0 ()
1203BT

  • Manual dental scaler, reusable
  • Dental excavator, reusable

Power Dental USA - D9431201BT00

X POWER TITANIUM BLACK H6/7
Power Dental U.S.A. Inc.
1201BT
In Commercial Distribution

  • D9431201BT00 ()
1201BT

  • Manual dental scaler, reusable
  • Dental excavator, reusable

Power Dental USA - D9431006F0

X POWER FLEX EXPLORERS-DOUBLE-END EXD 5
Power Dental U.S.A. Inc.
1006F
In Commercial Distribution

  • D9431006F0 ()
1006F

  • Dental surgical probe, reusable

Power Dental USA - D9434638

X POWER CROWN REMOVER KIT (4PCS)
Power Dental U.S.A. Inc.
4638
In Commercial Distribution

  • D9434638 ()
4638

  • Dental implant/prosthesis handling forceps
  • Orthodontic pliers

Power Dental USA - D9434103S0

POWER SURGICAL CURETTES 86S SERRATED 3.3mm
Power Dental U.S.A. Inc.
4103S
In Commercial Distribution

  • D9434103S0 ()
4103S

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable

Power Dental USA - D9433750DN0

X POWER FLAP OPENER DETACHABLE TITANIUM
Power Dental U.S.A. Inc.
3750DN
In Commercial Distribution

  • D9433750DN0 ()
3750DN

  • Dental elevator, tooth/root

Power Dental U.S.A., Inc. - D94335410

POWER PERIOSTEAL ELEVATOR/BONE PACKER (2-3-4-5-6-7-8-9-10)
Power Dental U.S.A. Inc.
3541
In Commercial Distribution

  • D94335410 ()
3541

  • Dental elevator, tooth/root
  • Periosteal elevator, reusable

Power Dental USA - D94335000

X POWER PERIOSTEAL SET OF 7
Power Dental U.S.A. Inc.
3500
In Commercial Distribution

  • D94335000 ()
3500

  • Periosteal elevator, reusable
  • Dental elevator, tooth/root

Power Dental U.S.A., Inc. - D943N40333

POWER FLEX TWIST PERIOTOME DOUBLE SIDE
Power Dental U.S.A. Inc.
N4033-3
In Commercial Distribution

  • D943N40333 ()
N4033-3

  • Dental elevator, tooth/root

Power Dental U.S.A., Inc. - D943N19902G00

X PERIOTOME POWER FLEX PT-1 POSTERIOR
Power Dental U.S.A. Inc.
N1990-2G
In Commercial Distribution

  • D943N19902G00 ()
N1990-2G

  • Periotome, reusable

Power Dental U.S.A., Inc. - D943N1979K00

POWER IMPLANT GUIDE KIT WITH CASSETTE
Power Dental U.S.A. Inc.
N1979K
In Commercial Distribution

  • D943N1979K00 ()
N1979K

  • General-purpose calliper, metallic

Power Dental U.S.A., Inc. - D943N1930S00

POWER PERIOTOME FLEX SET OF 3
Power Dental U.S.A. Inc.
N1930S
In Commercial Distribution

  • D943N1930S00 ()
N1930S

  • Periotome, reusable

Power Dental U.S.A., Inc. - D943N1930

POWER PERIOTOME FLEX SET OF 4
Power Dental U.S.A. Inc.
N1930
In Commercial Distribution

  • D943N1930 ()
N1930

  • Periotome, reusable

Power Dental USA - D9439022IMCR0

POWER CROWN REMOVER KIT (4 PCS)
Power Dental U.S.A. Inc.
9022-IMCR
In Commercial Distribution

  • D9439022IMCR0 ()
9022-IMCR

  • Dental implant/prosthesis handling forceps
  • Orthodontic pliers

Power Dental USA - D9437821

POWER ROOT EXTRACTION HANDPIECE ANCHOR 30mm
Power Dental U.S.A. Inc.
7821
In Commercial Distribution

  • D9437821 ()
7821

  • Dental spatula, reusable
  • Dental amalgam carrier
  • Steel dental bur, reusable

Power Dental USA - D9437818N00

POWER BONE TAC KIT WITH CASE
Power Dental U.S.A. Inc.
7818N
In Commercial Distribution

  • D9437818N00 ()
7818N

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use

Power Dental USA - D9437815

POWER IMPLANT REMOVER SINGLE OUT KIT
Power Dental U.S.A. Inc.
7815
In Commercial Distribution

  • D9437815 ()
7815

  • General-purpose calliper, metallic
  • Dressing/utility forceps, scissors-like, reusable
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