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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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Orbitum X Staple - B565FO100024160

24mm VI Hourglass Staple
CPM Medical Consultants, LLC
FO-1000-2416
In Commercial Distribution

  • B565FO100024160 ()


  • Orthopaedic bone staple, non-adjustable

Orbitum X Staple - B565FO100024140

24mm Round Staple
CPM Medical Consultants, LLC
FO-1000-2414
In Commercial Distribution

  • B565FO100024140 ()


  • Orthopaedic bone staple, non-adjustable

Orbitum X Staple - B565FO100020120

20mm Round Staple
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO100020120 ()
FO-1000-2012

  • Orthopaedic bone staple, non-adjustable, non-sterile

Orbitum X Staple - B565FO100016100

16mm Round Staple
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO100016100 ()
FO-1000-1610

  • Orthopaedic bone staple, non-adjustable, non-sterile

Orbitum X Staple - B565FO100012080

12mm Round Staple
CPM Medical Consultants, LLC
Rev A
In Commercial Distribution

  • B565FO100012080 ()
FO-1000-1208

  • Orthopaedic bone staple, non-adjustable, non-sterile

IN-OVATION ® X - D807289452101

In-Ovation ® X Base Rx 022/LL5 -22T -1A4DHK
DENTSPLY SIRONA ORTHODONTICS INC.
289-452-10
Not in Commercial Distribution

  • D807289452101 ()
  • D807289452100 ()
289-452-10

  • Orthodontic bracket, metal

IN-OVATION ® X - D807289451101

In-Ovation ® X Base Rx 018/LL5 -22T -1A4DHK
DENTSPLY SIRONA ORTHODONTICS INC.
289-451-10
Not in Commercial Distribution

  • D807289451101 ()
  • D807289451100 ()
289-451-10

  • Orthodontic bracket, metal

IN-OVATION ® X - D807289442101

In-Ovation ® X Base Rx 022/LL4 -17T -1A4DHK
DENTSPLY SIRONA ORTHODONTICS INC.
289-442-10
Not in Commercial Distribution

  • D807289442101 ()
  • D807289442100 ()
289-442-10

  • Orthodontic bracket, metal

IN-OVATION ® X - D807289412001

In-Ovation ® X Base Rx 022/LL1 & 2 -1T 2A
DENTSPLY SIRONA ORTHODONTICS INC.
289-412-00
Not in Commercial Distribution

  • D807289412001 ()
  • D807289412000 ()
289-412-00

  • Orthodontic bracket, metal

IN-OVATION ® X - D807289411001

In-Ovation ® X Base Rx 018/LL1 & 2 -1T 2A
DENTSPLY SIRONA ORTHODONTICS INC.
289-411-00
Not in Commercial Distribution

  • D807289411001 ()
  • D807289411000 ()
289-411-00

  • Orthodontic bracket, metal
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