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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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Next Gen Driver - M791NGD10000

No Description
BIOACCESS INC
NGD1000
In Commercial Distribution

  • M791NGD10000 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, single-use

NA - 10886982240149

BATTERY RECIPROCATOR II
Synthes GmbH
530.715
In Commercial Distribution

  • 07611819491854 ()
  • H6795307150 ()
  • 10886982240149 ()
530715

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

NA - 10886982240132

BATTERY OSCILLATOR II
Synthes GmbH
530.710
In Commercial Distribution

  • 07611819491847 ()
  • H6795307100 ()
  • 10886982240132 ()
530710

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

M.A.R.A Accessory Parts - D819900245

No Description
SPECIALTY APPLIANCES, LLC
900245
Not in Commercial Distribution

  • D819900245 ()


  • Orthodontic power arm
  • Orthodontic lock
  • Dental torque wrench
  • Orthodontic separator

Set Aquilon830 SR + Unifix 4H - J00717002130011

Set of micromotor and Accessory connects micro-motors to the console
Bien-Air Dental SA
1700213-001
In Commercial Distribution

  • J00717002130011 ()
1700213-001

  • Dental power tool system handpiece, pneumatic
  • Pneumatic dental handpiece coupler

M.A.R.A Accessory Parts - D8199002450

No Description
SPECIALTY APPLIANCES, LLC
900245
In Commercial Distribution

  • D8199002450 ()


  • Orthodontic power arm
  • Orthodontic lock
  • Dental torque wrench
  • Orthodontic separator

NA - 10886982130167

LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM
Synthes GmbH
05.001.241
In Commercial Distribution

  • 07611819462595 ()
  • H679050012410 ()
  • 10886982130167 ()
05001241

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

NA - 10886982130150

RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM
Synthes GmbH
05.001.240
In Commercial Distribution

  • 07611819462588 ()
  • H679050012400 ()
  • 10886982130150 ()
05001240

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

PHASOR - B775PH45070DPHKA10

Phasor Drill 4.50-mm diameter, ~70-mm length with Drill Stop Extension (untapered) + Kit (version A1)
PHASOR HEALTH LLC
PH-450-70-D + PH-K-A1
In Commercial Distribution

  • B775PH45070DPHKA10 ()
PH-450-70-D + PH-K-A1

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated

PHASOR - B775PH45070DPHKA0

Phasor Drill 4.50-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (version A)
PHASOR HEALTH LLC
PH-450-70-D + PH-K-A
In Commercial Distribution

  • B775PH45070DPHKA0 ()
PH-450-70-D + PH-K-A

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
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